Clinical trial · Observational
Retrospective Epidemiology Study Of ALK Rearrangement In Non-Small Cell Lung Cancer Patients In The Middle East & North Africa
RETROSPECTIVE EPIDEMIOLOGY STUDY OF ALK REARRANGEMENT IN NON-SMALL CELL LUNG CANCER PATIENTS IN THE MIDDLE EAST & NORTH AFRICA.
NCT02304406CI-TRIAL-00039581ALK NSCLC MENAcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Percentage of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Rearrangement
- timeFrame
- 3 years
- description
- 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).
Secondary outcomes (13)
- measure
- Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender
- timeFrame
- 3 years
- description
- In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the gender of study participants.
- measure
- Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.