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

August 4, 2017 updated by: British Columbia Cancer Agency

A Study to Compare the Performance of a qPCR-based Assay to Immunohistochemistry (IHC) and Fluorescence in Situ Hybridization (FISH) in the Detection of Anaplastic Lymphoma Kinase (ALK) Fusion Mutations in Formalin Fixed Paraffin-embedded (FFPE) Tissue From Non-small Cell Lung Cancer (NSCLC) Patients.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S 0C2
        • BC Cancer Agency-Abbotsford Centre
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • BC Cancer Agency-Centre for the Southern Interior
      • North Vancouver, British Columbia, Canada, V7L 2L7
        • Lions Gate Hospital
      • Prince George, British Columbia, Canada, V2N 7E9
        • BC Cancer Agency-Centre for the North
      • Surrey, British Columbia, Canada, V3V 1Z2
        • BC Cancer Agency, Frase Valley Centre
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Agency, Vancouver Centre
      • Victoria, British Columbia, Canada, V8R 6V5
        • BC Cancer Agency

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IHC, FISH and qPCR ALK assays
ALK testing by IHC and FISH will be compared to ALK qPCR testing on NSCLC FFPE tissue.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Up to 24 weeks after the completing of enrollment of 72 ALK negative and 72 ALK positive tumor blocks
Up to 24 weeks after the completing of enrollment of 72 ALK negative and 72 ALK positive tumor blocks

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: After completion of enrollemnt of 72 ALK postive tumor blocks.
After completion of enrollemnt of 72 ALK postive tumor blocks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Collaborators

Insight Genetics

Investigators

  • Principal Investigator: David L Saltman, MD PhD, British Columbia Cancer Agency
  • Principal Investigator: Aly Karsan, MD, BC Cancer Agency, Molecular Diagnostic Laboraotry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

August 18, 2015

Study Completion (ACTUAL)

August 18, 2015

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 9, 2013

First Posted (ESTIMATE)

December 12, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 4, 2017

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCRTALK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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