Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000998549
Ethics application status
Approved
Date submitted
17/07/2015
Date registered
24/09/2015
Date last updated
12/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lung Cancer Epidermal Growth Factor (EGFR) Gene Mutation Testing in New Zealand
Scientific title
Detection of Epidermal Growth Factor Receptor (EGFR) gene mutations in Lung cancer patients in New Zealand
Secondary ID [1] 287084 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 295594 0
Condition category
Condition code
Cancer 295870 295870 0 0
Lung - Non small cell

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a non-interventional observational study of EGFR gene somatic mutations in lung cancer patients in NZ. Epidermal growth factor receptor gene somatic mutations will be studied by review of test reports and retesting of samples issued and referred to Labplus medical laboratory at Auckland city hospital using polymerase chain reaction based techniques. Samples to be studied will be those referred to LabPLUS medical laboratory for routine epidermal growth factor receptor gene mutation testing. Each sample will be tested upon referral as part of standard care. Remnant samples remaining after routine testing will be stored and batched for future quality control retesting as per routine laboratory practice. As this is an observational non-interventional study it requires no direct involvement of its participants.

A study protocol amendment was prepared for the purposes of extending and expanding the population-based patient cohort study in order to more precisely determine the prevalence of genetic-defined forms of lung cancer in the New Zealand population; to include ALK, BRAF, EGFR, HER2, MET, RET and ROS-1 mutation-positive lung cancer; to understand the clinical and statistical significance of variations in disease prevalence between ethnic and other New Zealand population groups, and; to collect mature data on mortality and other clinical outcomes.
Intervention code [1] 292324 0
Not applicable
Comparator / control treatment
Not applicable, this is a non-interventional observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295549 0
Detection of an EGFR gene somatic muation by oncogene mutation detection protocols using quantitative real-time polymerase chain reaction and mass spectrometry genotyping of tumour samples from lung cancer patients.

Timepoint [1] 295549 0
Each sample will be tested upon referral as part of standard care. Remnant samples remaining after routine testing will be stored and batched for future Quality control retesting as per routine laboratory practice.
Secondary outcome [1] 316886 0
Nil
Timepoint [1] 316886 0
Nil

Eligibility
Key inclusion criteria
Patients residing in New Zealand presenting with non-small cell lung cancer of the non-squamous or not-otherwise-specified morphological subtypes over a two year period.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/11/2013
Actual
2/12/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/12/2018
Actual
Sample size
Target
2000
Accrual to date
9000
Final
Recruitment outside Australia
Country [1] 7032 0
New Zealand
State/province [1] 7032 0

Funding & Sponsors
Funding source category [1] 291645 0
Government body
Name [1] 291645 0
Health Research Council of New Zealand
Country [1] 291645 0
New Zealand
Primary sponsor type
Other
Name
Auckland UniServices Ltd
Address
Level 10, UniServices House,
70 Symonds Street, Auckland
Private Bag 92019, Victoria Street West,
Auckland 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 290314 0
None
Name [1] 290314 0
Address [1] 290314 0
Country [1] 290314 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293172 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 293172 0
Ministry of Health
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 293172 0
New Zealand
Date submitted for ethics approval [1] 293172 0
Approval date [1] 293172 0
12/11/2013
Ethics approval number [1] 293172 0
13/NTB/165

Summary
Brief summary
Lung cancer is a major cause of mortality and morbidity in New Zealand, especially among Maori compared to non-Maori. The potential was recognised for addressing these health disparities and poor outcomes by utilising targeted therapy for selected patients whose lung cancers harbour mutations in the Epidermal Growth Factor Receptor (EGFR) gene.
There has been very little research undertaken on EGFR mutation positive lung cancer in New Zealand. Consequently, virtually no information is available about it in the local lung cancer patient population. PHARMAC have made available publicly-funded gefitinib for the treatment of EGFR mutation positive lung cancer patients in New Zealand. However, no agreed national process was in place for EGFR gene mutation testing for eligible patients.
The main overall objective is to deliver evidence informing the implementation of EGFR gene mutation testing for guiding lung cancer patient selection for EGFR tyrosine kinase inhibitor drug treatment in New Zealand
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58770 0
Prof Mark McKeage
Address 58770 0
Dept of Pharmacology and Clinical Pharmacology,
The University of Auckland
85 Park Road, Grafton,
Private Bag 92019
AUCKLAND 1023
Country 58770 0
New Zealand
Phone 58770 0
+ 64 9 923 7322
Fax 58770 0
Email 58770 0
[email protected]
Contact person for public queries
Name 58771 0
Miss Prashannata Khwaounjoo
Address 58771 0
Dept of Pharmacology and Clinical Pharmacology,
The University of Auckland
85 Park Road, Grafton,
Private Bag 92019
AUCKLAND 1023
Country 58771 0
New Zealand
Phone 58771 0
+ 64 9 923 1594
Fax 58771 0
Email 58771 0
[email protected]
Contact person for scientific queries
Name 58772 0
Prof Mark McKeage
Address 58772 0
Dept of Pharmacology and Clinical Pharmacology,
The University of Auckland
85 Park Road, Grafton,
Private Bag 92019
AUCKLAND 1023
Country 58772 0
New Zealand
Phone 58772 0
+ 64 9 923 7322
Fax 58772 0
Email 58772 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLung cancer mutation testing: A clinical retesting study of agreement between a real-time PCR and a mass spectrometry test.2017https://dx.doi.org/10.18632/oncotarget.21023
EmbaseScreening for anaplastic lymphoma kinase (ALK) gene rearrangements in non-small-cell lung cancer in New Zealand.2020https://dx.doi.org/10.1111/imj.14435
Dimensions AI455P Population-level impact of EGFR mutation testing in nonsquamous NSCLC2016https://doi.org/10.1016/s0923-7534(21)00613-x
Dimensions AI454P Efficacy of crizotinib in NSCLC with concomitant ALK fusion and c-MET overexpression2016https://doi.org/10.1016/s0923-7534(21)00612-8
Dimensions AI453P Utility of re-biopsy and clinical predictive factors of T790M point mutation in EGFR mutated non-small lung cancer2016https://doi.org/10.1016/s0923-7534(21)00611-6
Dimensions AI452P Disease progression site and subsequent therapy after progression during alectinib therapy2016https://doi.org/10.1016/s0923-7534(21)00610-4
N.B. These documents automatically identified may not have been verified by the study sponsor.