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Trial registered on ANZCTR
Registration number
ACTRN12618000712202
Ethics application status
Approved
Date submitted
26/03/2018
Date registered
1/05/2018
Date last updated
6/08/2021
Date data sharing statement initially provided
2/04/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Embedding Research (and evidence) in Cancer Healthcare (EnRICH)
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Scientific title
Embedding Research (and evidence) in Cancer Healthcare (EnRICH)
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Secondary ID [1]
293455
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None
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Universal Trial Number (UTN)
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Trial acronym
EnRICH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Cancer
305634
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Condition category
Condition code
Cancer
304854
304854
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0
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Lung - Non small cell
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Cancer
304855
304855
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0
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Lung - Small cell
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
60
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Target follow-up type
Months
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Description of intervention(s) / exposure
The aim of this program is to assemble a patient cohort to describe the natural history of and patterns of care for lung cancer. Questionnaires and blood collection will be performed once at three, six, and twelve months, and annually thereafter. The duration of the program is at least five years. Questionnaires will take approximately 10-15min to complete. Tumour tissue taken at biopsy or surgical resection will be archived for sub-studies.
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Intervention code [1]
300431
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Patient timeline from symptom presentation to diagnosis as assessed by study-specific questionnaire and data linkage to medical records.
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Assessment method [1]
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Timepoint [1]
304905
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Baseline at enrolment, 3 months, 6 months, 12 months and annually thereafter up to 5 years.
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Secondary outcome [1]
343580
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Exploratory genetic screening using blood and tissue samples.
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Assessment method [1]
343580
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Timepoint [1]
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Baseline at enrolment, 3 months, 6 months, 12 months and annually thereafter up to 5 years. Tissue samples will only be obtained at biopsy or resection.
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Secondary outcome [2]
345053
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Exploratory biomarker screening using tissue and blood samples.
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Assessment method [2]
345053
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Timepoint [2]
345053
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Baseline, 3 month, 6 month, 12 month, and annually thereafter to the completion of 5 years. Tissue samples will only be obtained at biopsy or resection.
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Eligibility
Key inclusion criteria
All patients with lung cancer presenting to defined clinical sites for diagnosis or treatment, including:
Patients with a new diagnosis of primary lung cancer (any histological type, any pathological/clinical stage including metastatic) undergoing primary treatment (including observation and clinical advice that no anti-cancer therapy is necessary/appropriate); curative or palliative.
Patients with first progressive disease, local recurrence or new metastasis after completing previous curative treatment for non-metastatic disease at the time of initial diagnosis.
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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
Patients with a lung tumour which is a metastasis from a non-lung primary site.
Patients diagnosed with mesothelioma.
Patients with cognitive or intellectual impairment or significant mental illness who are unable to give informed consent.
Patients presenting for a second specialist opinion ONLY
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Characteristics of the Cohort will be described along with the tumour and treatment patterns. Recurrence free and overall survival will be estimated for key subgroups of patients using the Kaplan-Meier method and compared using log-rank tests where appropriate.
The sample size of 1000 patients will be sufficient to estimate proportions with 95% confidence intervals with width at most +/- 3.1% for the complete cohort, +/6.9% for 20% of the cohort (e.g. small cell carcinomas, KRAS2 mutation) and +/-9.8% for 10% of the cohort (e.g. large cell carcinomas).
Analysis of patient outcomes and guideline indicators will describe variability across disease, institutional and patient characteristics. Changes in outcomes and indicators over time will be estimated using longitudinal models with an emphasis on describing trends.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
16/05/2017
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Date of last participant enrolment
Anticipated
31/12/2021
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Actual
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Date of last data collection
Anticipated
31/12/2026
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Actual
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Sample size
Target
1000
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Accrual to date
622
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
10110
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
10111
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The Chris O’Brien Lifehouse - Camperdown
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Recruitment hospital [3]
10112
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Concord Repatriation Hospital - Concord
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Recruitment hospital [4]
10113
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St Vincent's Hospital (Darlinghurst) - Darlinghurst
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Recruitment hospital [5]
10114
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Bathurst Base Hospital - Bathurst
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Recruitment hospital [6]
10115
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Orange Health Service - Orange
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Recruitment hospital [7]
10116
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Dubbo Base Hospital - Dubbo
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Recruitment hospital [8]
10117
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Coffs Harbour Base Hospital - Coffs Harbour
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Recruitment postcode(s) [1]
21645
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2050 - Camperdown
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Recruitment postcode(s) [2]
21646
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2139 - Concord
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Recruitment postcode(s) [3]
21647
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2010 - Darlinghurst
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Recruitment postcode(s) [4]
21648
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2795 - Bathurst
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Recruitment postcode(s) [5]
21649
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2800 - Orange
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Recruitment postcode(s) [6]
21650
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2830 - Dubbo
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Recruitment postcode(s) [7]
21651
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2450 - Coffs Harbour
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Funding & Sponsors
Funding source category [1]
299312
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Government body
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Name [1]
299312
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Cancer Institute NSW
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Address [1]
299312
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8 Central Ave
Eveleigh
NSW 2015
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Country [1]
299312
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Australia
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Funding source category [2]
299313
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Hospital
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Name [2]
299313
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Sydney Local Health District
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Address [2]
299313
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Level 11, KGV Building
Missenden Road
CAMPERDOWN NSW 2050
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Country [2]
299313
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Australia
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Primary sponsor type
University
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Name
Sydney Catalyst Translational Cancer Research Centre, University of Sydney
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Address
NHMRC Clinical Trial Centre
Level 6, Chris O'Brien Lifehouse
119-143 Missenden Road
NSW 2050
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Country
Australia
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Secondary sponsor category [1]
298301
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None
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Name [1]
298301
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Address [1]
298301
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Country [1]
298301
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299102
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SLHD (RPAH Zone) Human Research Ethics Committee (HREC)
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Ethics committee address [1]
299102
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Research Ethics and Governance Office
Royal Prince Alfred Hospital
Camperdown NSW 2050
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Ethics committee country [1]
299102
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Australia
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Date submitted for ethics approval [1]
299102
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30/11/2016
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Approval date [1]
299102
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23/12/2016
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Ethics approval number [1]
299102
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X16-0447
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Summary
Brief summary
Short title EnRICH
Protocol number and date X16-0447 dated 29/03/2017
This study aims to assemble a patient cohort to describe the natural history of and patterns of care for lung cancer; identify current gaps in evidence and practice for clinical quality improvement.
Who is it for?
You may be eligible for this study if you are aged 18 or over and have a diagnosis of lung cancer and are attending a defined clinical site for diagnosis or treatment.
Study details
All participants will provide demographic information, and their medical records will be used to build a profile of the participant’s cancer, including clinical and outcome information. Participants will also provide around 3 blood samples for research taken at the time of routine collection (e.g. prior to commencement of treatment, post-treatment). Biopsied tumour samples will be used to screen for biomarkers and molecular signals of disease.
This research will assemble a patient cohort for identifying current gaps in evidence and practice, creating a platform for researchers across the translational research spectrum to develop and initiate studies to address these gaps.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
79294
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Prof John Simes
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Address
79294
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Level 6, Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown 2050 NSW
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Country
79294
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Australia
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Phone
79294
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+61 2 9562 5001
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Fax
79294
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Email
79294
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[email protected]
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Contact person for public queries
Name
79295
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Dr Bea Brown
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Address
79295
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Level 6, Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown 2050 NSW
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Country
79295
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Australia
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Phone
79295
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+61 2 8036 5248
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Fax
79295
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Email
79295
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[email protected]
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Contact person for scientific queries
Name
79296
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Dr Bea Brown
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Address
79296
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Level 6, Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown 2050 NSW
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Country
79296
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Australia
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Phone
79296
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+61 2 8036 5248
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Fax
79296
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Email
79296
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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