An Exploratory Study of ctDNA-MRD in Predicting the Efficacy of Esophageal Squamous Cell Carcinoma

Sponsor
Guangzhou Institute of Respiratory Disease (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05759325
Collaborator
(none)
100
45

Study Details

Study Description

Brief Summary

The purpose of this study is to observe and evaluate the correlation between ctDNA-MRD and the therapeutic effect and prognosis of stage II-IVA operable esophageal squamous cell carcinoma.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    ESCC patients with II-IVA resection will undergo MRD examination at the following time: the first examination is before the operation, the second examination is 7-10 days after the operation, and then 1 month after the operation, 2 weeks after the end of adjuvant treatment (if available), the follow-up period (every 3 months if there is no postoperative treatment) and the progress (the progress of the disease confirmed by the researcher), the patients will receive close MRD monitoring to evaluate the correlation between ctDNA-MRD and therapeutic efficacy and prognosis.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Application of ctDNA-MRD in the Prediction of Curative Effect, Recurrence Monitoring and Prognosis Evaluation of Esophageal Squamous Cell Carcinoma (ESCC) During Perioperative Treatment
    Anticipated Study Start Date :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    Mar 1, 2026
    Anticipated Study Completion Date :
    Dec 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [up to 2 year]

      Evaluation of progression-free survival rate of esophageal squamous cell carcinoma patients with different MRD status during perioperative period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Patients with stage II-IVA Esophageal squamous cell carcinoma confirmed by clinical pathological staging;

    2. ≥18 years;

    3. Eastern Cooperative Oncology Group performance status score (ECOG PS) is 0 ~ 1 points;

    4. Expected survival time ≥ 6 months;

    5. Patients agree and have the ability to follow the planned study visits, laboratory tests and other research steps.

    Exclusion Criteria:
    1. Patients with other malignant tumors;

    2. Patient had undergone surgery before admission;

    3. Pregnant or lactating women;

    4. Patients with other serious diseases;

    5. Patients who could not understand the experiment content and could not cooperate with them and refused to sign the informed consent form;

    6. Patients with contraindications to radiotherapy and chemotherapy;

    7. Other researchers think it is not suitable.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Guangzhou Institute of Respiratory Disease

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jun Liu, GuangzhouIRD, Guangzhou Institute of Respiratory Disease
    ClinicalTrials.gov Identifier:
    NCT05759325
    Other Study ID Numbers:
    • ESCC ctDNA-MRD
    First Posted:
    Mar 8, 2023
    Last Update Posted:
    Mar 8, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jun Liu, GuangzhouIRD, Guangzhou Institute of Respiratory Disease
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 8, 2023