Retrospective Epidemiology Study Of ALK Rearrangement In Non-Small Cell Lung Cancer Patients In The Middle East & North Africa
NCT02304406
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- 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.
- 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.
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Descriptive Information | |||||
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Brief Title | 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. | ||||
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. | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Retrospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description: 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. | ||||
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. | ||||
Condition | Non-small Cell Lung Cancer | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment | 449 | ||||
Original Estimated Enrollment | 700 | ||||
Actual Study Completion Date | February 11, 2018 | ||||
Actual Primary Completion Date | February 11, 2018 (Final data collection date for primary outcome measure) | ||||
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:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Egypt, Lebanon, Morocco, Saudi Arabia, United Arab Emirates | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT02304406 | ||||
Other Study ID Numbers | A8081046 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Pfizer | ||||
Verification Date | May 2019 |