Comparison of qPCR to IHC and FISH for Detection of ALK Fusion Mutations in FFPE Tissue From NSCLC Patients (PCRTALK)

British Columbia Cancer Agency

Status: Completed

Conditions: Nonsmall Cell Lung Cancer

Treatments: Device: ALK qPCR assay

Study type: Interventional

Funder types: Other

Identifiers

NCT02010047

PCRTALK

Details and patient eligibility

About

The anaplastic lymphoma kinase gene(ALK) is mutated approximately 5% of non-small cell lung cancers. Testing for this gene is important because there are drugs known as ALK inhibitors that have been shown to significantly delay the progression of ALK-mutated lung cancers. There are a number of ways to test for the presence of the ALK gene in lung cancer biopsy tissue. One method involves making slides and staining them to detect the ALK protein. This is called immunohistochemistry. Another method called fluorescence in situ hybridization(FISH)is used to detect rearrangements of the ALK gene associated with lung cancer. Although both these tests are widely used to test for ALK gene abnormalities, the techniques may not always find the ALK gene mutation because they are not sensitive enough or not enough cancer cells are present in the lung biopsy.

This study is being performed to determine if a technique called quantitation polymerase chain reaction (qPCR) is as accurate or better at finding the ALK gene mutation in lung cancer biopsy tissue.

Enrollment: 166 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• You have a confirmed diagnosis of non-squamous, non-endocrine non-small cell lung cancer.
• Your cancer biopsy has sufficient cancer cells to be tested for the (Epidermal Growth Factor Receptor (EGFR) mutation, the ALK fusion gene abnormality and the research ALK testing.
• Your lung cancer biopsy is determined not to have a mutation in the EGFR gene.
• You are 19 years old or older.
• You fully understand the study and give informed consent to participate as demonstrated by signing the consent.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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166 participants in 1 patient group

IHC, FISH and qPCR ALK assays

Experimental group

Description:

ALK testing by IHC and FISH will be compared to ALK qPCR testing on NSCLC FFPE tissue.

Treatment:

Device: ALK qPCR assay