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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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ClinicalTrials.gov Identifier: NCT03236675
Recruitment Status : Unknown
Verified February 2019 by Exosome Diagnostics, Inc..
Recruitment status was:  Active, not recruiting
First Posted : August 2, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Exosome Diagnostics, Inc.

Study Description
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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.

Condition or disease
Carcinoma, Non-Small-Cell Lung

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients
Study Start Date : March 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

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Groups and Cohorts
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Group/Cohort
EML4-ALK
ALK positive patients
T790M EGFR
T790M positive patients


Outcome Measures
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Primary Outcome Measures :
  1. ALK mutation by tissue assay. [ Time Frame: 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.

  2. T790M EGFR mutation by tissue assay [ Time Frame: 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.


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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Community sample
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03236675


Locations
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United States, Florida
Memorial Healthcare System
Hollywood, Florida, United States, 33021
United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
Exosome Diagnostics, Inc.
Investigators
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Study Director: Roger Tun Exosome Diagnostics, Inc.
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Exosome Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT03236675    
Other Study ID Numbers: ECT2015-003A
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases