Skip to content

Lung Cancer Epidermal Growth Factor (EGFR) Gene Mutation Testing in New Zealand

Detection of Epidermal Growth Factor Receptor (EGFR) gene mutations in Lung cancer patients in New Zealand

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12615000998549
Enrollment
9000
Registered
2015-09-24
Start date
2013-12-02
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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 testin

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.

Sponsors

Auckland UniServices Ltd
Lead SponsorOther

Eligibility

Sex/Gender
All
Healthy volunteers
No

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.

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 8, 2026