Status:
COMPLETED
Retrospective Epidemiology Study Of ALK Rearrangement In Non-Small Cell Lung Cancer Patients In The Middle East & North Africa
Lead Sponsor:
Pfizer
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
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...
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 re...
Eligibility Criteria
Inclusion
- \- 1. Histological confirmation of nonsquamous NSCLC, with any TNM stage. 2. Available and sufficient tissue sample for ALK testing 3.Tissue samples are less than 5 years old 4.Routinely processed formalin-fixed, paraffin-embedded tissue samples only (see exclusion criteria pertaining to tissue samples).
- Histological sections mounted on glass slides must not be older than 3 months 6.Age \> 18 years 7.Any ECOG Performance status 8.Still alive, or death confirmed before inclusion, or is unknown 9.Disease diagnosis and/or treatment in one of the centers, in the last 5 years, assigned to participate in the study; 10.Written informed consent for general investigational testing was previously obtained, or specifically obtained for this retrospective epidemiology study, or having a documented waiver for the Informed consent document use, as required by local regulatory authorities, \&/or Research Ethics committee/Institutional Review Board.
Exclusion
- 1- Tumor tissue samples older than 5 year period or samples not properly stored.
- 2-Tumor tissue samples fixed by using AFA, B5, Bouin's, 95% ETOH, \& alcohol fixatives.
- 3-Under-fixed tissue samples (i.e. \< 6 hrs) 4-Tumor tissue samples that have been subject to any decalcification processes. 5-Recycled paraffin-embedded tissue samples. 6-Cut slides stored longer than 3 months. 7-Insufficient tissue samples with less tumor cells \& high amount of necrosis.
Key Trial Info
Start Date :
January 21 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 11 2018
Estimated Enrollment :
449 Patients enrolled
Trial Details
Trial ID
NCT02304406
Start Date
January 21 2015
End Date
February 11 2018
Last Update
July 19 2019
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
National Cancer Institute
Cairo, Egypt
2
National Cancer Institute
Cairo / Misr Al Qadimah, Egypt
3
American University in Beirut
Beirut, Lebanon
4
American University of Beirut
Beirut, Lebanon