Creating a model to monitor residual breast cancer after surgery using blood samples

Exploratory Research on Constructing a Computational Biological Model Based on Next Generation Sequencing Technology for Monitoring Measurable Residual Disease (MRD) After Breast Cancer Surgery

This study is testing if analyzing blood samples can help monitor leftover breast cancer after surgery in patients over three years.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06595966 on ClinicalTrials.gov

What this trial studies

This observational study involves 80 participants who have undergone radical breast cancer surgery. Blood samples will be collected at various intervals over a three-year follow-up period to analyze changes in circulating free DNA (cfDNA) associated with measurable residual disease (MRD). The goal is to establish a computational biological model using next-generation sequencing to enhance monitoring of MRD in breast cancer patients post-surgery. Traditional monitoring methods will also be evaluated alongside cfDNA analysis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have undergone radical resection for primary breast cancer and can commit to a three-year follow-up.

Not a fit: Patients who are pregnant, breastfeeding, or have serious mental illness or drug abuse issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate monitoring of residual breast cancer, potentially improving patient outcomes.

How similar studies have performed: While similar approaches using cfDNA for cancer monitoring have shown promise, this specific model is novel and has not been extensively tested.

Eligibility criteria

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;

Where this trial is running

Hangzhou, Zhejiang

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

Study contacts

• Study coordinator: Chao Ni, professor

Conditions: Breast Cancer, Measurable Residual Disease