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

Not Applicable

Completed

• Conditions: Nonsmall Cell Lung Cancer
• Interventions: Device: ALK qPCR assay

• Registration Number: NCT02010047
• Lead Sponsor: British Columbia Cancer Agency

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-12
• Status Verified: 2014-07
• Primary Completion: 2015-08-18
• Study Completion: 2015-08-18
• Last Update Submitted: 2017-08-04
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IHC, FISH and qPCR ALK assays	ALK qPCR assay	ALK testing by IHC and FISH will be compared to ALK qPCR testing on NSCLC FFPE tissue.

Primary Outcome Measures

Name	Time	Method
To determine the true number of ALK positives and negatives of a qPCR assay for the detection in FFPE lung cancer biopsy specimens of ALK status in comparison with IHC and FISH ALK detection technologies.	Up to 24 weeks after the completing of enrollment of 72 ALK negative and 72 ALK positive tumor blocks

Secondary Outcome Measures

Name	Time	Method
The analysis of plasma and serum collected from those patients with ALK-positive NSCLC to assess the feasibility for the use of non-invasive sampling in the diagnosis and disease monitoring of lung cancer.	After completion of enrollemnt of 72 ALK postive tumor blocks.

Trial Locations

Locations (7)

BC Cancer Agency-Abbotsford Centre; 🇨🇦 Abbotsford, British Columbia, Canada

BC Cancer Agency-Centre for the North; 🇨🇦 Prince George, British Columbia, Canada

BC Cancer Agency, Frase Valley Centre; 🇨🇦 Surrey, British Columbia, Canada

BC Cancer Agency, Vancouver Centre; 🇨🇦 Vancouver, British Columbia, Canada

Lions Gate Hospital; 🇨🇦 North Vancouver, British Columbia, Canada

BC Cancer Agency-Centre for the Southern Interior; 🇨🇦 Kelowna, British Columbia, Canada

BC Cancer Agency; 🇨🇦 Victoria, British Columbia, Canada