Ignite Creation Date:
2024-05-06 @ 3:29 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02304406
Status:
COMPLETED
Last Update Posted:
2019-07-19
First Post:
2014-11-14
Brief Title:
Retrospective Epidemiology Study Of ALK Rearrangement In Non-Small Cell Lung Cancer Patients In The Middle East North Africa
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
RETROSPECTIVE EPIDEMIOLOGY STUDY OF ALK REARRANGEMENT IN NON-SMALL CELL LUNG CANCER PATIENTS IN THE MIDDLE EAST NORTH AFRICA
Status:
COMPLETED
Status Verified Date:
2019-05
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 NSCLC MENA
Brief Summary:
Thet study aims to estimate the prevalence of ALK rearrangement in the Middle East North Africa population by using the Ventana ALK-IHC method for ALK protein detection in retrospective NSCLC clinical samples to evaluate the association of ALK rearrangement with clinical and pathological parameters of NSCLC patients in MENA
Detailed Description:
This is a retrospective cross-sectional non-interventional epidemiology study to investigate the prevalence of ALK rearrangement in NSCLC patients in Middle East North Africa Approximately 700 retained tumor tissue specimens tissue block of patients previously diagnosed with NSCLC will be selected subjected to ALK immune-staining using Ventana anti-ALK D5F3 Rabbit Monoclonal Primary Antibody combined with OptiView Benchmark System in 6-8 centers in 5-7 countries in the MENA region
The tissue samples of NSCLC cases will be retrieved from tissue banks of the molecular diagnostic units pathology departments in these study centers The histological diagnosis will be confirmed by the pathologists The retained samples will then be tested by performing the Ventana ALK-IHC to assess the absence or presence of the ALK rearrangement by the detection of the ALK protein in formalin-fixed paraffin-embedded NSCLC stored tissue samples using Ventana anti-ALK D5F3 Rabbit Monoclonal Primary Antibody Roche Diagnostics GmbH in the selected study centers The results of ALK testing within this study population will then be used to establish the prevalence of ALK rearrangement in MENA NSCLC patients
The patients characteristics demographic clinical and pathologic parameters will be obtained from their medical records analyzed to determine any association with the presence of the EML4-ALK fusion gene in MENA NSCLC patients
The assessment of concordance of the results between FISH IHC will be done in 2-3 centers Results of FISH testing will be collected recorded if the retained tissue samples had been previously tested If not the Vysis FISH test will be performed to assess the concordance between the results obtained using Vysis Break-apart FISH Ventana IHC testing methods for ALK rearrangement detection
The tissue samples of NSCLC cases will be retrieved from tissue banks of the molecular diagnostic units pathology departments in these study centers The histological diagnosis will be confirmed by the pathologists The retained samples will then be tested by performing the Ventana ALK-IHC to assess the absence or presence of the ALK rearrangement by the detection of the ALK protein in formalin-fixed paraffin-embedded NSCLC stored tissue samples using Ventana anti-ALK D5F3 Rabbit Monoclonal Primary Antibody Roche Diagnostics GmbH in the selected study centers The results of ALK testing within this study population will then be used to establish the prevalence of ALK rearrangement in MENA NSCLC patients
The patients characteristics demographic clinical and pathologic parameters will be obtained from their medical records analyzed to determine any association with the presence of the EML4-ALK fusion gene in MENA NSCLC patients
The assessment of concordance of the results between FISH IHC will be done in 2-3 centers Results of FISH testing will be collected recorded if the retained tissue samples had been previously tested If not the Vysis FISH test will be performed to assess the concordance between the results obtained using Vysis Break-apart FISH Ventana IHC testing methods for ALK rearrangement detection
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