Lung Cancer Clinical Trial

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

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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.

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Full 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 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.

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Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Study is for people with:

Lung Cancer

Estimated Enrollment:

60

Study ID:

NCT03236675

Recruitment Status:

Active, not recruiting

Sponsor:

Exosome Diagnostics, Inc.

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There are 2 Locations for this study

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Memorial Healthcare System
Hollywood Florida, 33021, United States
Ochsner Medical Center
New Orleans Louisiana, 70121, United States

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Study is for people with:

Lung Cancer

Estimated Enrollment:

60

Study ID:

NCT03236675

Recruitment Status:

Active, not recruiting

Sponsor:


Exosome Diagnostics, Inc.

How clear is this clinincal trial information?

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