Clinical trial NCT06595966: Exploratory Research on Constructing a Computational Biological Model Based on NGS for MRD After Breast Cancer Surgery
Official title: Exploratory Research on Constructing a Computational Biological Model Based on Next Generation Sequencing Technology for Monitoring Measurable Residual Disease (MRD) After Breast Cancer Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Measurable Residual Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eighty patients with breast cancer were diagnosed in the Second Affiliated Hospital of Zhejiang University School of Medicine.

Brief 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;

Detailed 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;

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\&#39;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;

Primary outcomes:
measure: Sample Sizes
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References: