Exploratory Research on Constructing a Computational Biological Model Based on NGS for MRD After Breast Cancer Surgery

Last updated: September 11, 2024
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT06595966
2023-0693
  • Ages > 18
  • Female

Study Summary

This study will include 80 subjects after radical breast cancer resection, collect blood samples of the above subjects, observe and quantify the characteristic changes of cfDNA in the blood of breast cancer subjects after surgery, and establish a computational biological model based on next generation sequencing to monitor breast cancer MRD;

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years old, gender not limited; 2. Obtain plasma samples from thesubjects during a 3-year follow-up period; 3. The subjects fully understand thestudy and voluntarily sign the informed consent form; 4. Able to cooperate witha 3-year follow-up visit to the hospital; 5. The physical fitness status score (ZPS) of the ECOG scoring criteria for the subjects must be ≤ 1; 6. Lifeexpectancy ≥ 5 years; 7. Subjects who meet the following criteria:

  2. Histopathology confirmed primary breast cancer (unlimited molecular type);

  3. Radical breast cancer resection is expected;

  4. Adopting postoperative adjuvant therapy or preoperative neoadjuvant therapy;

Exclusion

Exclusion Criteria:

  1. The subject is pregnant or breastfeeding; 2. Serious mental illness or drugabuse; 3. Unable to obtain the subject's plasma during this period; 4. Ifthe subject has a non primary malignant tumor of the breast with a clearpathological diagnosis within 5 years before enrollment: 5. If the subject hassuspected non breast malignant tumors (such as B-ultrasound, CT, etc.) onimaging within the past year of enrollment, but without pathologicalconfirmation; 6. Clinical suspicion of distant metastatic lesions; 7. Thesubject has received any blood product infusion therapy within the past 30days; 8. Known carriers of pathogenic genetic mutations;

Study Design

Total Participants: 80
Study Start date:
June 01, 2023
Estimated Completion Date:
June 01, 2026

Study Description

This study will include 80 subjects after radical breast cancer resection. The results of CA15-3, CEA, color Doppler ultrasound and other traditional postoperative monitoring examinations for breast cancer, as well as 5ml of peripheral venous blood, were collected on the day of enrollment/the 7th day after adjuvant treatment/the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, 24th, 30th and 36th months after surgery. We observe and quantify the characteristic changes of cfDNA in the blood of breast cancer subjects after surgery, and establish a computational biological model based on next generation sequencing to monitor breast cancer MRD;

Connect with a study center

  • The Second Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

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