Status:
UNKNOWN
Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients
Lead Sponsor:
Exosome Diagnostics, Inc.
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Brief Summary
Demonstrate feasibility of detection of EML4-ALK fusion transcripts and T790M EGFR mutation from exosomes in the circulation of Non-Small Cell Lung Cancer (NSCLS) patients.
Detailed Description
The goal of this study is two-fold: 1) Demonstrate feasibility of detection of EML4-ALK fusion transcripts in the circulation of NSCLC patients positive for ALK on tissue analysis, using an institutio...
Eligibility Criteria
Inclusion
- Participants must have histologically confirmed NSCLC, stage IIIB- IV, and have tested positive for the presence of EML4-ALK on tissue specimen, fresh or archived, using an institutionally accepted assay.
- Age of 18 years or older.
- Participants are being considered for ALK-directed therapy or have progressed on EGFR TKI treatment.
- Participants must have hemoglobin \> 10 mg/dL.
- Ability to understand and willingness to sign a written informed consent document.
Exclusion
- Hepatitis (all types) in patient's medical record
- HIV documented in patient's medical record
- Hemoglobin \< 10 mg/dL
- Less than 18 years of age
- Histologically confirmed NSCLC Stage I-IIIA
- Tested negative for the presence of EML4-ALK and T790M EGFR on tissue
Key Trial Info
Start Date :
March 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03236675
Start Date
March 1 2015
End Date
February 1 2022
Last Update
September 30 2021
Active Locations (2)
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1
Memorial Healthcare System
Hollywood, Florida, United States, 33021
2
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121