Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2022-02-28

Brief Summary

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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.

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Detailed Description

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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 institutionally accepted assay; 2) Demonstrate feasibility of detection of T790M EGFR mutation in the circulation of NSCLC patients positive for T790M on tissue analysis, using an institutionally accepted assay.

Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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EML4-ALK

ALK positive patients

No interventions assigned to this group

T790M EGFR

T790M positive patients

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes