Ignite Creation Date:
2024-05-06 @ 12:48 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01662635
Status:
COMPLETED
Last Update Posted:
2019-01-09
First Post:
2012-08-08
Brief Title:
Clinicopathological Features of NSCLC Patients Associated With the Chromosome 2p EML4-ALK
Sponsor:
Instituto Nacional de Cancerologia de Mexico
Organization:
Instituto Nacional de Cancerologia de Mexico
Study Overview
Official Title:
CLINICOPATHOLOGICAL FEATURES OF NON-SMALL CELL LUNG CANCER PATIENTS ASSOCIATED WITH THE CHOROMOSOME 2p EML4-ALK INVERSION IN MEXICAN POPULATION
Status:
COMPLETED
Status Verified Date:
2016-08
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:
ALK
Brief Summary:
Because ALK-positive lung cancer constitutes less than 5 of all lung cancers it is critically important to select those patients who are more likely to have the ALK mutation Clinical characteristics of patients with mutations in the target gene should also be known so that the incidence of a given target mutation is established in a specific population There is not incidence known in Mexican population but it is believed it is greater
Detailed Description:
Lung adenocarcinoma studies The only inclusion criterion was the availability of tissue for biomarker studies To identify ALK rearrangements fluorescence in situ hybridization FISH studies were performed on 3 to 4 mm thick paraffin sections from NSCLCs The commercially labeled Vysis LSI ALK Dual Color split-apart break-apart rearrangement probe Abbott Molecular Abbott Park IL was used to detect any rearrangement involving the ALK gene The probe hybridizes to band 2p23 on either side of the ALK gene breakpoint Criteria for probe signal interpretation in at least 200 interphase nuclei were as follow 1 separated green and orange signals or single red signals identified cells with rearranged ALK 2 overlapping of red and green signals yellowish indicated cells in which ALK was not rearranged
FISH-positive samples for ALK rearrangement were defined as having cells with a clearly separated pair of probe signals or with 15 of cells having loss of the 5centromeric probe The higher threshold for loss is necessary because parts of probes can be lost during sectioning
The aim of our study is to evaluate the utility of IHC with 5A4 and RT-qPCR in the detection of ALK rearrangements in NSCLC compared with the current method of choice FISH Further we report on the demographics and clinicopathologic features of ALK-rearranged NSCLC in a Latin-American population
Clinical details of these patients were included in a database Further results will be analyzed with the program SPSS17
FISH-positive samples for ALK rearrangement were defined as having cells with a clearly separated pair of probe signals or with 15 of cells having loss of the 5centromeric probe The higher threshold for loss is necessary because parts of probes can be lost during sectioning
The aim of our study is to evaluate the utility of IHC with 5A4 and RT-qPCR in the detection of ALK rearrangements in NSCLC compared with the current method of choice FISH Further we report on the demographics and clinicopathologic features of ALK-rearranged NSCLC in a Latin-American population
Clinical details of these patients were included in a database Further results will be analyzed with the program SPSS17
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