Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02010047
Status:
COMPLETED
Last Update Posted:
2017-08-08
First Post:
2013-12-05
Brief Title:
Comparison of qPCR to IHC and FISH for Detection of ALK Fusion Mutations in FFPE Tissue From NSCLC Patients
Sponsor:
British Columbia Cancer Agency
Organization:
British Columbia Cancer Agency
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PCRTALK
Brief Summary:
The anaplastic lymphoma kinase geneALK 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 hybridizationFISHis 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None