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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03236675
• Other study ID #: ECT2015-003A
• Status: Active, not recruiting
• Start date: March 2015
• Est. completion date: February 2022

Study information

• Verified date: September 2021
• Source: Exosome Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Locations

Country	Name	City	State
United States	Memorial Healthcare System	Hollywood	Florida
United States	Ochsner Medical Center	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Exosome Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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