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

Recruiting now

Conditions studied: Breast Cancer, Measurable Residual Disease

In brief

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;

Key facts

Study ID

NCT06595966

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

80

Starts

2023-06-01

Expected to finish

2026-06-01

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Histopathology confirmed primary breast cancer (unlimited molecular type);
• Radical breast cancer resection is expected;
• Adopting postoperative adjuvant therapy or preoperative neoadjuvant therapy;

You may not qualify if…

• 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;

Where it is running

• The Second Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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