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Circulating Tumor DNA Monitoring in Breast Cancer Undergoing Neoadjuvant Therapy

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05649475
Collaborator
(none)
100
Enrollment
1
Location
47
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In the prospective, open, observational study, we aim to evaluate whether circulating tumor DNA (ctDNA) can be the marker of the response to neoadjuvant therapy in stage I-III breast cancer.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Circulating Tumor DNA Monitoring in Breast Cancer Undergoing Neoadjuvant Therapy
    Actual Study Start Date :
    Aug 31, 2021
    Anticipated Primary Completion Date :
    Jul 31, 2024
    Anticipated Study Completion Date :
    Jul 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Patients receiving neoadjuvant therapy

    Outcome Measures

    Primary Outcome Measures

    1. Miller-Payne grading system [3 years]

    2. Residual cancer burden (RCB) [3 years]

    Eligibility Criteria

    Criteria

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

    • Patient is ≥ 18 years-old at the time of consent to participate this trial

    • Patients with stage I-III invasive breast cancer

    • No prior anti-cancer treatment

    • Felt to be a possible candidate for neoadjuvant therapy by their physician

    Exclusion Criteria:

    • Known to have other aggressive malignant tumor in the past 5 years.

    • Breast cancer during lactation; Inflammatory breast cancer; Acute inflammatory disease, pregnancy and other conditions may affect the levels of ctDNA and/or peripheral inflammatory indicators.

    • There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia.

    • The investigator determines that subjects are not appropriate to participate in the study due to other factors.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 2nd Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou China

    Sponsors and Collaborators

    • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT05649475
    Other Study ID Numbers:
    • 2021-0532
    First Posted:
    Dec 14, 2022
    Last Update Posted:
    Dec 14, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Dec 14, 2022