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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 30, 2021 · Source: ClinicalTrials.gov
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Observational
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
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.
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.