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.
View this trial on ClinicalTrials.gov
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