Retrospective Epidemiology Study Of ALK Rearrangement In Non-Small Cell Lung Cancer Patients In The Middle East & North Africa

Pfizer449 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

449

Conditions

Non-small Cell Lung Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- 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). 5.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 Criteria: * 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.

Locations (11)

National Cancer Institute

Cairo, Egypt

National Cancer Institute

Cairo / Misr Al Qadimah, Egypt

American University in Beirut

Beirut, Lebanon

American University of Beirut

Outcomes

Primary Outcomes

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).

Time frame: 3 years

Secondary Outcomes

Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender

In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the gender of study participants.

Time frame: 3 years

Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race

In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the race of study participants.

Time frame: 3 years

Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History

In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the smoking history of study participants as participants who never smoked, current smoker and ex-smoker.

Time frame: 3 years

Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis

In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the diagnosis of tumor histology of study participants.

Time frame: 3 years

Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage

Data from ClinicalTrials.gov

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