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| Name | Class |
|---|---|
| Insight Genetics | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IHC, FISH and qPCR ALK assays | Experimental | ALK testing by IHC and FISH will be compared to ALK qPCR testing on NSCLC FFPE tissue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALK qPCR assay | 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. |
| Measure | Description | 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. | Up to 24 weeks after the completing of enrollment of 72 ALK negative and 72 ALK positive tumor blocks |
| Measure | Description | 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. | After completion of enrollemnt of 72 ALK postive tumor blocks. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David L Saltman, MD PhD | British Columbia Cancer Agency | Principal Investigator |
| Aly Karsan, MD | BC Cancer Agency, Molecular Diagnostic Laboraotry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer Agency-Abbotsford Centre | Abbotsford British Columbia | British Columbia | V2S 0C2 | Canada | ||
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| BC Cancer Agency-Centre for the Southern Interior |
| Kelowna |
| British Columbia |
| V1Y 5L3 |
| Canada |
| Lions Gate Hospital | North Vancouver | British Columbia | V7L 2L7 | Canada |
| BC Cancer Agency-Centre for the North | Prince George | British Columbia | V2N 7E9 | Canada |
| BC Cancer Agency, Frase Valley Centre | Surrey | British Columbia | V3V 1Z2 | Canada |
| BC Cancer Agency, Vancouver Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| BC Cancer Agency | Victoria | British Columbia | V8R 6V5 | Canada |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |