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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03236675

Enrollment

Registered

2017-08-02

Start date

2015-03-31

Completion date

2022-02-28

Last updated

2021-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

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 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
ALK mutation by tissue assay.	Two years	Patients found to be positive for ALK mutation by tissue assay. ALK fusions in samples will be considered binary - positive or negative/ not assessable. 2x2 table will be constructed to determine concordance with tissue testing.
T790M EGFR mutation by tissue assay	Two years	Patients found to be positive for T790M EGFR mutation by tissue assay. ALK fusions in samples will be considered binary - positive or negative/ not assessable. 2x2 table will be constructed to determine concordance with tissue testing.

Countries

United States

Outcome results