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

NCT ID: NCT02010047

Last Updated: 2017-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-08-18

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.

Conditions

Nonsmall Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

IHC, FISH and qPCR ALK assays

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

Group Type: EXPERIMENTAL

ALK qPCR assay

Intervention Type: DEVICE

72 IHC ALK-negative and 72 IHC ALK-positive FFPE samples will tested with FISH and qPCR to determine the sensitivity and specificity of the ALK qPCR assay.

Interventions

ALK qPCR assay

72 IHC ALK-negative and 72 IHC ALK-positive FFPE samples will tested with FISH and qPCR to determine the sensitivity and specificity of the ALK qPCR assay.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insight Genetics

UNKNOWN

Sponsor Role: collaborator

British Columbia Cancer Agency

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David L Saltman, MD PhD

Role: PRINCIPAL_INVESTIGATOR

British Columbia Cancer Agency

Aly Karsan, MD

Role: PRINCIPAL_INVESTIGATOR

BC Cancer Agency, Molecular Diagnostic Laboraotry

Locations

BC Cancer Agency-Abbotsford Centre

Abbotsford, British Columbia, Canada

BC Cancer Agency-Centre for the Southern Interior

Kelowna, British Columbia, Canada

Lions Gate Hospital

North Vancouver, 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

BC Cancer Agency

Victoria, British Columbia, Canada

Countries

Canada

Other Identifiers

PCRTALK

Identifier Type: -

Identifier Source: org_study_id