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Recurrence Monitoring in NSCLC Using Circulating Tumor DNA

Sponsor
Scripps Translational Science Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03878537
Collaborator
Scripps Health (Other), Lexent Bio, Inc. (Industry)
50
Enrollment
1
Location
33.6
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research study is investigating the role of cell free tumor DNA profiling in determining disease relapse and/or progression for patients with advanced NSCLC.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The objective of this study is to determine the ability of cell free tumor DNA genomic profiling to predict disease relapse or progression while on therapy for advanced stage NSCLC in comparison to current standard objective measures of disease relapse or progression.

    This study is a prospective observational study. The investigators will assess whole genome sequencing from patient blood samples collected alongside routine blood draws with each treatment cycle to determine the tumor load score at each timepoint while on therapy. CT images will be obtained at routinely ordered timepoints throughout therapy and will be used in the assessment for standard clinical or radiographic evidence of disease progression. These methods of measuring disease progression will be compared in a lead time analysis.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Recurrence Monitoring in NSCLC Using Circulating Tumor DNA
    Actual Study Start Date :
    Mar 14, 2019
    Actual Primary Completion Date :
    Mar 1, 2021
    Anticipated Study Completion Date :
    Dec 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival [24 months]

      Cell free tumor DNA based PFS

    2. Progression Free Survival [24 months]

      Clinical or radiographic based PFS

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Treatment naïve biopsy confirmed not surgically resectable stage III or greater NSCLC

    • Baseline CT imaging available

    Exclusion Criteria:

    • Patients unable to undergo biopsy for initial tissue diagnosis

    • Patients who do not wish to pursue standard of care therapy

    • Patients with another diagnosis of malignancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scripps Health/Scripps Clinic Hillcrest/Scripps Clinic Torrey Pines San Diego California United States 92103

    Sponsors and Collaborators

    • Scripps Translational Science Institute
    • Scripps Health
    • Lexent Bio, Inc.

    Investigators

    • Principal Investigator: Marin Xavier, Scripps Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aditya Sarvaria, MD, Investigator, Scripps Translational Science Institute
    ClinicalTrials.gov Identifier:
    NCT03878537
    Other Study ID Numbers:
    • IRB-17-7057
    First Posted:
    Mar 18, 2019
    Last Update Posted:
    Mar 23, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Recurrence

    Study Results

    No Results Posted as of Mar 23, 2021