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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01788163
Registration number
NCT01788163
Ethics application status
Date submitted
7/02/2013
Date registered
11/02/2013
Date last updated
17/05/2017
Titles & IDs
Public title
Asia Pacific and Russia Diagnostic Study for EGFR Testing
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Scientific title
A Diagnostic Study to Determine the Prevalence of EGFR Mutations in Asian and Russian Patients With Advanced NSCLC of Adenocarcinoma and Non-adenocarcinoma Histologies
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Secondary ID [1]
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D7913C00074
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Universal Trial Number (UTN)
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Trial acronym
IGNITE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
EGFR Mutation Status in aNSCLC Patients
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - EGFR mutation test
Other: Locally advanced/metastatic NSCLC pats. - Patients with locally advanced (stage IIIA/B) or metastatic NSCLC who have not received any local or systemic chemotherapy, and are not eligible for curative treatment (including surgery and chemoradiotherapy)
Treatment: Other: EGFR mutation test
EGFR mutation being tested in tissue and blood
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status
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Assessment method [1]
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The 95% Confidence intervals were calculated using Clopper Pearson method for each country.
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Timepoint [1]
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At Screening
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Primary outcome [2]
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Tumour EGFR Mutation by Subtype
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Assessment method [2]
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Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.
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Timepoint [2]
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At Screening
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Primary outcome [3]
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Tumour EGFR Mutation Status by Histology
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Assessment method [3]
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Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country.
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Timepoint [3]
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At Screening
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Primary outcome [4]
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Overall Plasma EGFR Mutation Status
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Assessment method [4]
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Plasma samples were only performed in China, Taiwan, South Korea and Russia. The Confidence intervals were calculated using Clopper Pearson method for each country.
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Timepoint [4]
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At Screening
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Primary outcome [5]
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Plasma EGFR Mutation by Subtype
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Assessment method [5]
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Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.
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Timepoint [5]
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At Screening
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Primary outcome [6]
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Plasma EGFR Mutation Status by Histology
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Assessment method [6]
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Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country
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Timepoint [6]
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At Screening
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Secondary outcome [1]
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Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples
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Assessment method [1]
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Plasma samples were only performed in China, Taiwan, South Korea and Russia.
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Timepoint [1]
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At Screening
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Secondary outcome [2]
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Sensitivity and Specificity of Comparison of Mutation Status Between Tumour and Plasma Samples
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Assessment method [2]
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Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants only include those who had sensitivity and specificity tests performed.
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Timepoint [2]
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At Screening
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Secondary outcome [3]
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Predictive Values of Comparison of Mutation Status Between Tumour and Plasma Samples
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Assessment method [3]
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Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants include only those who had Positive and Negative Predictive tests performed.
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Timepoint [3]
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At Screening
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Secondary outcome [4]
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Tumour EGFR Mutation Testing
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Assessment method [4]
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Frequencies of tumour EGFR mutation testing practices parameters.
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Timepoint [4]
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At Screening
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Secondary outcome [5]
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Tumour EGFR Mutation Testing Rates
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Assessment method [5]
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Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation.
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Timepoint [5]
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At Screening
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Secondary outcome [6]
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Tumour EGFR Mutation Testing Turnaround Time
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Assessment method [6]
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Tumour EGFR mutation testing turnaround time is the number of days from the test request to getting the test result.
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Timepoint [6]
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At Screening
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Secondary outcome [7]
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Plasma EGFR Mutation Testing
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Assessment method [7]
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Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequencies of plasma EGFR mutation testing practices parameters.
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Timepoint [7]
0
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At Screening
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Secondary outcome [8]
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Plasma EGFR Mutation Testing Rates
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Assessment method [8]
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Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation. Plasma samples were only performed in China, Taiwan, South Korea and Russia.
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Timepoint [8]
0
0
At Screening
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Secondary outcome [9]
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Plasma EGFR Mutation Testing Turnaround Time
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Assessment method [9]
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Plasma samples were only performed in China, Taiwan, South Korea and Russia. Plasma EGFR mutation testing turnaround time is the number of days from the test request to getting the test result.
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Timepoint [9]
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At Screening
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Secondary outcome [10]
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Demographics and Disease Characteristics by Tumour EGFR Mutation Status
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Assessment method [10]
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Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry.
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Timepoint [10]
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At Screening
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Secondary outcome [11]
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Time Since First Non-small-cell Lung Carcinoma (NSCLC) Diagnosis by Tumor EGFR Mutation
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Assessment method [11]
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Number of months since the first diagnosis of NSCLC from informed consent date.
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Timepoint [11]
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At Screening
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Secondary outcome [12]
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Number of Organs With Metastasis by Tumour EGFR Mutation Status
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Assessment method [12]
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Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.
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Timepoint [12]
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At Screening
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Secondary outcome [13]
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Demographics and Disease Characteristics by Plasma EGFR Mutation Status
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Assessment method [13]
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Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry.
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Timepoint [13]
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At Screening
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Secondary outcome [14]
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Time Since First NSCLC Diagnosis by Plasma EGFR Mutation
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Assessment method [14]
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Number of months since the first diagnosis of NSCLC from informed consent date.
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Timepoint [14]
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At Screening
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Secondary outcome [15]
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Number of Organs With Metastasis by Plasma EGFR Mutation Status
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Assessment method [15]
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Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.
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Timepoint [15]
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At Screening
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Secondary outcome [16]
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First Line Treatment Choice by Asia Pacific Country
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Assessment method [16]
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0
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Timepoint [16]
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At Screening
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Secondary outcome [17]
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First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
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Assessment method [17]
0
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Timepoint [17]
0
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At Screening
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Eligibility
Key inclusion criteria
* Histological or cytological confirmed locally advanced NSCLC (stage IIIA/B) not suitable for curative treatment or metastatic (stage IV) NSCLC
* Newly diagnosed patients with locally advanced and/or metastatic NSCLC who are systemic treatment Naive (i.e. no chemotherapy or EGFR-TKI) or patients with recurrent disease who have previously received adjuvant chemotherapy (not including EGFR-TKI)
* Provision of diagnostic cancer tissue or cytology sample upon inclusion (surgical specimen, biopsy sample, or cytology sample is acceptable) and Provision of a routine blood (plasma) sample in China, Russia, Taiwan and Korea
* Patients aged 18 years and older
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
* Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study
* Pregnancy or breast-feeding
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/02/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/06/2016
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Sample size
Target
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Accrual to date
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Final
3500
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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Research Site - Campbelltown
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Recruitment hospital [2]
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Research Site - Coffs Harbour
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Recruitment hospital [3]
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Research Site - Concord
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Recruitment hospital [4]
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Research Site - Tamworth
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Recruitment hospital [5]
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Research Site - Tweed Heads
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Recruitment hospital [6]
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Research Site - Wahroonga
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Recruitment hospital [7]
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Research Site - Brisbane
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Recruitment hospital [8]
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Research Site - Woolloongabba
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Recruitment hospital [9]
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Research Site - Murdoch
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Recruitment postcode(s) [1]
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- Campbelltown
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Recruitment postcode(s) [2]
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- Coffs Harbour
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Recruitment postcode(s) [3]
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- Concord
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Recruitment postcode(s) [4]
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- Tamworth
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Recruitment postcode(s) [5]
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- Tweed Heads
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Recruitment postcode(s) [6]
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- Wahroonga
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Recruitment postcode(s) [7]
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- Brisbane
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Recruitment postcode(s) [8]
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- Woolloongabba
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Recruitment postcode(s) [9]
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- Murdoch
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Recruitment outside Australia
Country [1]
0
0
China
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State/province [1]
0
0
Beijing
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Country [2]
0
0
China
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State/province [2]
0
0
Changsha
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Country [3]
0
0
China
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State/province [3]
0
0
Changzhou
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Country [4]
0
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China
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State/province [4]
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0
Chengdu City
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Country [5]
0
0
China
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State/province [5]
0
0
Chengdu
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Country [6]
0
0
China
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State/province [6]
0
0
Chongqing
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Country [7]
0
0
China
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State/province [7]
0
0
Foshan City
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Country [8]
0
0
China
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State/province [8]
0
0
Guangzhou
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Country [9]
0
0
China
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State/province [9]
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0
Hangzhou City
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Country [10]
0
0
China
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State/province [10]
0
0
Hangzhou
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Country [11]
0
0
China
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State/province [11]
0
0
Nanjing
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Country [12]
0
0
China
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State/province [12]
0
0
Shanghai
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Country [13]
0
0
China
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State/province [13]
0
0
Suzhou City
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Country [14]
0
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China
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State/province [14]
0
0
Taiyuan
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Country [15]
0
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China
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State/province [15]
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Wuhan City
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Country [16]
0
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China
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State/province [16]
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Zhengzhou
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Country [17]
0
0
Indonesia
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State/province [17]
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Jakarta
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Country [18]
0
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Indonesia
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State/province [18]
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Surabaya
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Country [19]
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Korea, Republic of
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State/province [19]
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Cheongju
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Country [20]
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Korea, Republic of
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State/province [20]
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Daegu
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Country [21]
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Korea, Republic of
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State/province [21]
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Seoul
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Country [22]
0
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Malaysia
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State/province [22]
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Kuala Lumpur
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Country [23]
0
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Russian Federation
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State/province [23]
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0
Arkhangelsk
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Country [24]
0
0
Russian Federation
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State/province [24]
0
0
Barnaul
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Country [25]
0
0
Russian Federation
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State/province [25]
0
0
Belgorod
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Country [26]
0
0
Russian Federation
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State/province [26]
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0
Birobidzhan
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Country [27]
0
0
Russian Federation
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State/province [27]
0
0
Chelyabinsk
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Country [28]
0
0
Russian Federation
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State/province [28]
0
0
Chita
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Country [29]
0
0
Russian Federation
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State/province [29]
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0
Irkutsk
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Country [30]
0
0
Russian Federation
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State/province [30]
0
0
Izhevsk
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Country [31]
0
0
Russian Federation
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State/province [31]
0
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Kazan
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Country [32]
0
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Russian Federation
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State/province [32]
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Kemerovo
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Country [33]
0
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Russian Federation
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State/province [33]
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Khabarovsk
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Country [34]
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Russian Federation
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State/province [34]
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Khanty-Mansisk
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Country [35]
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Russian Federation
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State/province [35]
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Krasnodar
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Country [36]
0
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Russian Federation
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State/province [36]
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Krasnoyarsk
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Country [37]
0
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Russian Federation
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State/province [37]
0
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Lipetsk
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Country [38]
0
0
Russian Federation
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State/province [38]
0
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Moscow
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Country [39]
0
0
Russian Federation
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State/province [39]
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Novosibirsk
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Country [40]
0
0
Russian Federation
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State/province [40]
0
0
Obninsk
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Country [41]
0
0
Russian Federation
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State/province [41]
0
0
Omsk
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Country [42]
0
0
Russian Federation
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State/province [42]
0
0
Orel
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Country [43]
0
0
Russian Federation
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State/province [43]
0
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Perm
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Country [44]
0
0
Russian Federation
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State/province [44]
0
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Pyatigorsk
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Country [45]
0
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Russian Federation
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State/province [45]
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Rostov-on-Don
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Country [46]
0
0
Russian Federation
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State/province [46]
0
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Ryazan
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Country [47]
0
0
Russian Federation
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State/province [47]
0
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Samara
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Country [48]
0
0
Russian Federation
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State/province [48]
0
0
St. Petersburg
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Country [49]
0
0
Russian Federation
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State/province [49]
0
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Surgut
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Country [50]
0
0
Russian Federation
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State/province [50]
0
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Tula
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Country [51]
0
0
Russian Federation
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State/province [51]
0
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Ufa
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Country [52]
0
0
Russian Federation
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State/province [52]
0
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Velikiy Novgorod
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0
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Russian Federation
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State/province [53]
0
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Vladivostok
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Country [54]
0
0
Russian Federation
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State/province [54]
0
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Volgograd
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Country [55]
0
0
Russian Federation
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State/province [55]
0
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Yakutsk
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Country [56]
0
0
Russian Federation
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State/province [56]
0
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Yaroslavl
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Country [57]
0
0
Russian Federation
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State/province [57]
0
0
Yuzhno-Sakhalinsk
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Country [58]
0
0
Singapore
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State/province [58]
0
0
Singapore
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Country [59]
0
0
Taiwan
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State/province [59]
0
0
Kaohsiung
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Country [60]
0
0
Taiwan
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State/province [60]
0
0
Tainan City
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Country [61]
0
0
Taiwan
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State/province [61]
0
0
Tainan
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Country [62]
0
0
Taiwan
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State/province [62]
0
0
Taipei
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Country [63]
0
0
Thailand
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State/province [63]
0
0
Chiang Mai
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Country [64]
0
0
Thailand
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State/province [64]
0
0
Khon Kaen
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Country [65]
0
0
Thailand
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State/province [65]
0
0
Patumwan Bangkok
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. It will be conducted in Asia Pacific and Russia and will assess the current status of EGFR mutation testing, and the concordance of EGFR mutation status derived from tumour samples and blood based circulating free DNA.
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Trial website
https://clinicaltrials.gov/study/NCT01788163
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Rose McCormack, PhD
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Address
0
0
AstraZeneca, PHB
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01788163
Download to PDF