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Isolating and Testing Circulating Tumor DNA and Soluble Immune Markers During the Course of Treatment for Lung Cancer

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02410603
Collaborator
(none)
64
Enrollment
1
Location
49
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to explore the detection of circulating tumor DNA, soluble immune markers, and the evaluation of peripheral blood mononuclear cells (PBMC).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Our plan is to collect blood from patients with advanced stage lung cancer who are scheduled to undergo systemic therapy. In this study we will utilize a novel technology for circulating tumor DNA detection in order to evaluate their presence in patients with lung cancer by comparing blood samples at six time points. We will obtain baseline blood and then collect blood at five time points during the course of the patient's chemotherapy treatments and at the end of treatment. These same blood collections will be used for the detection of soluble immune markers and evaluation of PBMCs.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    64 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Isolating and Testing Circulating Tumor DNA and Soluble Immune Markers During the Course of Treatment for Lung Cancer
    Study Start Date :
    Dec 1, 2016
    Actual Primary Completion Date :
    Jan 1, 2021
    Actual Study Completion Date :
    Jan 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. The primary end point is the number and type of mutations detectable in the circulating tumor DNA blood samples. [1 year]

    Eligibility Criteria

    Criteria

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

    • Advanced (non-resectable) malignancy in the thorax

    • Age >18 years old

    • Willing and able to provide consent

    • No prior history of neoadjuvant therapy

    Exclusion Criteria:

    • Age <18 years old

    • Unable to provide consent

    • Patients with hemoglobin less than 10 g/dL (to minimize the impact of potential iatrogenic anemia)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Aaron Mansfield, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Aaron S. Mansfield, M.D., PI, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02410603
    Other Study ID Numbers:
    • 15-000373
    First Posted:
    Apr 7, 2015
    Last Update Posted:
    Jul 21, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Aaron S. Mansfield, M.D., PI, Mayo Clinic
    Chemotherapy
    Additional relevant MeSH terms:
    Carcinoma
    Lung Neoplasms
    Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Jul 21, 2021