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Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection

Sponsor
University Health Network, Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT05254782
Collaborator
Princess Margaret Cancer Foundation (Other), Inivata (Industry), Ontario Institute for Cancer Research (Other)
360
Enrollment
3
Locations
47.8
Anticipated Duration (Months)
120
Patients Per Site
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

ctDNALung-Detect is an investigator-initiated single arm, multi-institution study designed to assess the ctDNA detection rate and its association with Relapse Free Survival (RFS) in operable stage T1-T4 (T3,T4 multifocal) N0M0 non-small cell lung cancer (NSCLC) patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    360 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    From Liquid Biopsy to Cure: Using ctDNA Detection of Minimal Residual Disease to Identify Patients for Curative Therapy After Lung Cancer Resection (ctDNALung-Detect)
    Actual Study Start Date :
    Jul 6, 2021
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Jun 30, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Rate of ctDNA Detection [Up to 24 Months]

      The percentages of pre-operative and post-operative ctDNA detection in patients with T1-T4N0 (T3, T4 multifocal) NSCLC will be estimated together with their Clopper-Pearson exact 95% CIs.

    2. Relapse Free Survival [Up to 36 Months]

      Relapse free survival (RFS) will be estimated using the Kaplan-Meier method and compared using the logrank test among patients with and without detectable ctDNA pre- or post-operatively.

    Secondary Outcome Measures

    1. Overall Survival [Up to 36 Months]

      Overall survival (OS) will be estimated using the Kaplan-Meier method and compared using the log-rank test between patients with and without detectable ctDNA pre- or post-operatively.

    Eligibility Criteria

    Criteria

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

    1. Age ≥ 18 years;

    2. Ability to provide written informed consent;

    3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

    4. T1-T4 (T3,T4 multifocal) N0M0 NSCLC who are planned for complete surgical resection;

    5. Tumour size must be at least 1 cm (unidimensional) and have at least some solid component on imaging;

    6. Surgical tumour formalin-fixed, paraffin-embedded (FFPE) specimens for ctDNA studies are required.

    Exclusion Criteria:

    1. Prior radiation, surgery or chemotherapy for the current diagnosis of NSCLC is not permitted.

    2. Incomplete surgical resection. Participants who had pre-operative ctDNA samples taken but subsequently do not have a complete surgical resection would not qualify for post-operative ctDNA testing.

    3. Concurrent enrolment in a therapeutic study using drug or radiation therapy. Enrolment in observational, diagnostic or studies of novel surgical techniques will be allowed.

    4. Concurrent active malignancy or other invasive malignancy within previous 2 years. Non-invasive malignancies (i.e., cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured) are excluded from this definition.

    5. Pregnancy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Michael Garron Hospital Toronto Ontario Canada
    2 St. Joseph's Health Centre Toronto Ontario Canada
    3 University Health Network Toronto Ontario Canada

    Sponsors and Collaborators

    • University Health Network, Toronto
    • Princess Margaret Cancer Foundation
    • Inivata
    • Ontario Institute for Cancer Research

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT05254782
    Other Study ID Numbers:
    • 20-6199
    First Posted:
    Feb 24, 2022
    Last Update Posted:
    Feb 24, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Neoplasm, Residual

    Study Results

    No Results Posted as of Feb 24, 2022