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Exploratory Research on Constructing a Computational Biological Model Based on NGS for MRD After Breast Cancer Surgery
RECRUITINGSponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University
Actively Recruiting
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Started2023-06-01
Est. completion2026-06-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06595966
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
Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria: * 1\. Age ≥ 18 years old, gender not limited; 2. Obtain plasma samples from the subjects during a 3-year follow-up period; 3. The subjects fully understand the study and voluntarily sign the informed consent form; 4. Able to cooperate with a 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. Life expectancy ≥ 5 years; 7. Subjects who meet the following criteria: 1. Histopathology confirmed primary breast cancer (unlimited molecular type); 2. Radical breast cancer resection is expected; 3. Adopting postoperative adjuvant therapy or preoperative neoadjuvant therapy; Exclusion Criteria: * 1\. The subject is pregnant or breastfeeding; 2. Serious mental illness or drug abuse; 3. Unable to obtain the subject\'s plasma during this period; 4. If the subject has a non primary malignant tumor of the breast with a clear pathological diagnosis within 5 years before enrollment: 5. If the subject has suspected non breast malignant tumors (such as B-ultrasound, CT, etc.) on imaging within the past year of enrollment, but without pathological confirmation; 6. Clinical suspicion of distant metastatic lesions; 7. The subject has received any blood product infusion therapy within the past 30 days; 8. Known carriers of pathogenic genetic mutations;
Conditions3
Breast CancerCancerMeasurable Residual Disease
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Actively Recruiting
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Started2023-06-01
Est. completion2026-06-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06595966