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

NCT03236675 | Unknown

• 1 other identifier: ECT2015-003A
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (2)

• ALK mutation by tissue assay.

  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.

  Two years

• T790M EGFR mutation by tissue assay

  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.

  Two years

Study Arms (2)

EML4-ALK

ALK positive patients

T790M EGFR

T790M positive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community sample

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Exosome Diagnostics, Inc.: lead

Study Sites (2)

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

10-20 mL of whole blood collected in K2EDTA Plasma Preparation Tubes (PPT) will be acquired via standard venipuncture. This will be an observational study as subjects will only provide plasma specimens at different time points and no therapeutic or intervention will be received outside of their normal standard of care.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Roger Tun

  Exosome Diagnostics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: August 2, 2017
• Study Start: March 1, 2015
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

US (2)