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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
166
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.
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
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
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.
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