Retrospective Epidemiology Study Of ALK Rearrangement In Non-Small Cell Lung Cancer Patients In The Middle East & North Africa
ALK NSCLC MENA
RETROSPECTIVE EPIDEMIOLOGY STUDY OF ALK REARRANGEMENT IN NON-SMALL CELL LUNG CANCER PATIENTS IN THE MIDDLE EAST & NORTH AFRICA.
1 other identifier
observational
449
5 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Typical duration for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2014
CompletedFirst Posted
Study publicly available on registry
December 2, 2014
CompletedStudy Start
First participant enrolled
January 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2018
CompletedResults Posted
Study results publicly available
July 19, 2019
CompletedJuly 19, 2019
May 1, 2019
3.1 years
November 14, 2014
January 24, 2019
May 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Rearrangement
Participants with prevalence of ALK rearrangement were positive for ALK: defined as presence of strong granular cytoplasmic staining in tumor cells (any percentage of positive tumor cells).
3 years
Secondary Outcomes (13)
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender
3 years
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race
3 years
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History
3 years
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis
3 years
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage
3 years
- +8 more secondary outcomes
Eligibility Criteria
Since this is a retrospective epidemiology study, no patients will be enrolled. Tissue samples of non-squamous NSCLC cases less than 5 years old from each of the centers will be selected.
You may not qualify if:
- Tumor tissue samples older than 5 year period or samples not properly stored.
- Tumor tissue samples fixed by using AFA, B5, Bouin's, 95% ETOH, \& alcohol fixatives.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (11)
National Cancer Institute
Cairo, Egypt
National Cancer Institute
Cairo / Misr Al Qadimah, Egypt
American University in Beirut
Beirut, Lebanon
American University of Beirut
Beirut, Lebanon
Institut National d'Oncologie
Rabat, Morocco
King Abdulaziz Medical City - National Guard Hospital
Riyadh, Saudi Arabia
King Faisal Specialty Hospital, Riyadh/Oncology Department
Riyadh, Saudi Arabia
King Faisal Specialty Hospital
Riyadh, Saudi Arabia
National Guard Hospital
Riyadh, Saudi Arabia
Tawam Hospital
Al Ain City, United Arab Emirates
Tawam Hospital
Al Ain/Al Maqam, United Arab Emirates
Related Links
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2014
First Posted
December 2, 2014
Study Start
January 21, 2015
Primary Completion
February 11, 2018
Study Completion
February 11, 2018
Last Updated
July 19, 2019
Results First Posted
July 19, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.