Clinical trial NCT02304406: Retrospective Epidemiology Study Of ALK Rearrangement In Non-Small Cell Lung Cancer Patients In The Middle East & North Africa
Official title: RETROSPECTIVE EPIDEMIOLOGY STUDY OF ALK REARRANGEMENT IN NON-SMALL CELL LUNG CANCER PATIENTS IN THE MIDDLE EAST & NORTH AFRICA.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Keywords: prevalence of ALK rearrangement, NSCLC, MENA
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-12-02
Enrollment: 449
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Rearrangement
timeFrame: 3 years
Secondary outcomes:
measure: Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender
timeFrame: 3 years
measure: Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race
timeFrame: 3 years
measure: Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History
timeFrame: 3 years
measure: Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis
timeFrame: 3 years
measure: Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage
timeFrame: 3 years
measure: Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type
timeFrame: 3 years
measure: Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Progression Free Survival (PFS)
timeFrame: 3 years
measure: Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Line of Therapy
timeFrame: 3 years
measure: Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR)
timeFrame: 3 years
measure: Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Participant's Status
timeFrame: 3 years
measure: Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status
timeFrame: 3 years
measure: Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Knowledge Representation for Autonomous Systems (KRAS) Status
timeFrame: 3 years
measure: Percentage Agreement Between Vysis Fluorescent In Situ Hybridization (FISH) and Ventana Immunohistochemistry (IHC) Methods for ALK Rearrangement Detection
timeFrame: 3 years
Other outcomes:
Locations:
city: Cairo / Misr Al Qadimah
country: Egypt
facility: National Cancer Institute
city: Cairo
country: Egypt
facility: National Cancer Institute
city: Beirut
country: Lebanon
facility: American University in Beirut
city: Beirut
country: Lebanon
facility: American University of Beirut
city: Rabat
country: Morocco
facility: Institut National d'Oncologie
city: Riyadh 12713
country: Saudi Arabia
facility: King Faisal Specialty Hospital, Riyadh/Oncology Department
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City - National Guard Hospital
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialty Hospital
city: Riyadh
country: Saudi Arabia
facility: National Guard Hospital
city: Al Ain/Al Maqam
country: United Arab Emirates
facility: Tawam Hospital
city: Al Ain
country: United Arab Emirates
facility: Tawam Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: