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Exploration on the Value of MRD Based on ctDNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer

Sponsor
Shanghai Pulmonary Hospital, Shanghai, China (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05965024
Collaborator
(none)
377
Enrollment
1
Location
60
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Based on the unique patented MONOD and Methyl Titan methylation sequencing technology on lung cancer tissue and blood samples, a lung cancer MRD monitoring panel is designed. The panel is used to detect molecular residual disease of stage IB-IIIB non-small cell lung cancer patients underwent radical surgery, explore personalized analysis models, and conduct research on recurrence monitoring for non-small cell lung cancer patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    377 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Exploration on the Value of Molecular Residual Disease Based on Circulating Tumor DNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer
    Anticipated Study Start Date :
    Aug 1, 2023
    Anticipated Primary Completion Date :
    Aug 1, 2026
    Anticipated Study Completion Date :
    Aug 1, 2028

    Outcome Measures

    Primary Outcome Measures

    1. 2-year recurrence-free survival rate [Up to 24 months]

      Recurrence-free survival means the time from the date of surgery to the first recorded date of disease recurrence or patient death, whichever occurs earlier. 2-year recurrence-free survival rate means the rate of patients survive without recurrence for 2 years or more.

    Secondary Outcome Measures

    1. Median recurrence-free survival [up to 60 months]

      Recurrence-free survival means the time from the date of surgery to the first recorded date of disease recurrence or patient death, whichever occurs earlier. Median recurrence-free survival means the median value of recurrence-free survival.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Age ≥ 18 years old, regardless of gender;

    2. Patients with pathological diagnosis of non-small cell lung cancer and clinical staging of stage IB-IIIB;

    3. Able to undergo radical surgical treatment;

    4. Physical condition score (ECOG) ≤1;

    5. The expected survival time exceeds 24 months;

    6. Volunteer to participate in this study and sign an informed consent form.

    Exclusion Criteria:

    1. Individuals with a history of other malignant tumors within 5 years;

    2. Those who have undergone neoadjuvant therapy before surgery;

    3. Postoperative incision margin R1 or incision margin R2;

    4. Those who have undergone a blood transfusion within 2 weeks before the surgery;

    5. Individuals with systemic inflammatory response syndrome;

    6. Those with serious diseases of important organs such as the heart, lungs, kidneys, and brain;

    7. Participants in other clinical trials within the past 30 days and have taken investigational drugs;

    8. Due to various reasons, sampling cannot be completed, samples do not meet the requirements, or baseline samples (preoperative and postoperative plasma samples, tumor tissue samples) are incomplete;

    9. Researchers believe that it is not appropriate to participate in this experiment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Pulmonary Hospital Shanghai Shanghai China 200433

    Sponsors and Collaborators

    • Shanghai Pulmonary Hospital, Shanghai, China

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peng Zhang, Professor, Shanghai Pulmonary Hospital, Shanghai, China
    ClinicalTrials.gov Identifier:
    NCT05965024
    Other Study ID Numbers:
    • LungMate-016
    First Posted:
    Jul 28, 2023
    Last Update Posted:
    Jul 28, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Recurrence

    Study Results

    No Results Posted as of Jul 28, 2023