Retrospective Epidemiology Study Of ALK Rearrangement In Non-Small Cell Lung Cancer Patients In The Middle East & North Africa
Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02304406 ↗Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Rearrangement |
8.69 | — |
| SECONDARY Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender |
10.1; 5.7 | 0.1304 |
| SECONDARY Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race |
11.1; 8.5; 0; 0 | 0.6422 |
| SECONDARY Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History |
9.0; 7.5; 5.8; 11.9 | 0.4524 |
| SECONDARY Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis |
8.6; 16.7; 0; 9.1 | 0.9010 |
| SECONDARY Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage |
6.3; 7.8; 6.3; 0; 10.0; 10.0 | 0.9067 |
| SECONDARY Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type |
7.5; 5.2; 10.0; 10.4; 7.8; 9.9 | 0.8785 |
| SECONDARY Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Progression Free Survival (PFS) |
8.0 | 0.9231 |
| SECONDARY Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Line of Therapy |
9.1; 8.5; 9.4; 3.1 | 0.9780 |
| SECONDARY Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR) |
14.3; 20.0; 7.6; 1.8; 9.9; 0 | 0.1144 |
| SECONDARY Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Participant's Status |
8.2; 11.1; 33.3 | 0.0862 |
| SECONDARY Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status |
12.0; 6.8; 0; 0; 14.3 | 0.0294 sig |
| SECONDARY Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Knowledge Representation for Autonomous Systems (KRAS) Status |
9.0; 0; 0; 0 | 0.6877 |
| SECONDARY Percentage Agreement Between Vysis Fluorescent In Situ Hybridization (FISH) and Ventana Immunohistochemistry (IHC) Methods for ALK Rearrangement Detection |
98.45 | — |
Summary
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.
Data sourced from ClinicalTrials.gov (NCT02304406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.