Nonsmall Cell Lung Cancer Clinical Trial
— PCRTALKOfficial title:
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.
Verified date | July 2014 |
Source | British Columbia Cancer Agency |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 166 |
Est. completion date | August 18, 2015 |
Est. primary completion date | August 18, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | 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 |
Lead Sponsor | Collaborator |
---|---|
British Columbia Cancer Agency | Insight Genetics |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. |
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