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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;
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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sample Sizes | The number of samples that meet the requirements meets the statistical requirements | 3 years |
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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:
Exclusion Criteria:
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Eighty patients with breast cancer were diagnosed in the Second Affiliated Hospital of Zhejiang University School of Medicine.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Ni, professor | Contact | +8613989463951 | nicaho428@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 7, 2023 | Sep 10, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 7, 2023 | Sep 10, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |