Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients
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.
Checked against the public recordLast updated Sep 30, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Exosome Diagnostics, Inc.
- Interventions being studied
- Not specified
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 1. 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. 2. Age of 18 years or older. 3. Participants are being considered for ALK-directed therapy or have progressed on EGFR TKI treatment. 4. Participants must have hemoglobin \> 10 mg/dL. 5. Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: 1. Hepatitis (all types) in patient's medical record 2. HIV documented in patient's medical record 3. Hemoglobin \< 10 mg/dL 4. Less than 18 years of age 5. Histologically confirmed NSCLC Stage I-IIIA 6. Tested negative for the presence of EML4-ALK and T790M EGFR on tissue
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Memorial Healthcare SystemHollywood, Florida
- Ochsner Medical CenterNew Orleans, Louisiana
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 30, 2021. Always confirm current availability with the study team.