Clinical Application of ctDNA in Early Screening of Breast Cancer

Study Overview
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Brief Summary
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The investigators aim to evaluate the possibility of clinical application of ctDNA detection in peripheral blood of normal people, benign breast disease patients and breast cancer patients, so as to act as the new techniques or indicators of early screening of breast cancer.

Official Title
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Clinical Application of ctDNA in Early Screening of Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Low depth whole genome sequencing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures. Age of at least 18 and at most 70 years. Normal people who works as the volunteers. Benign breast disease patients should be diagnosed with confirmed pathology after surgery. Breast cancer patients should be diagnosed with confirmed pathology after surgery, and with no clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration, which should be earlier than TNM IIA stage. Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution. Exclusion Criteria: Known hypersensitivity reaction to the investigational compounds or incorporated substances. Local recurrence and/or metastasis of breast cancer. Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration. Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix). Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study. Concurrent treatment with other experimental drugs or any other anti-cancer therapy. Males.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal people<br> | Diagnostic Test: Low depth whole genome sequencing<br>* Low depth whole genome sequencing of the peripheral blood samples from different groups.<br>|
| Benign breast disease patients<br> | Diagnostic Test: Low depth whole genome sequencing<br>* Low depth whole genome sequencing of the peripheral blood samples from different groups.<br>|
| Breast cancer patients in early stage<br> | Diagnostic Test: Low depth whole genome sequencing<br>* Low depth whole genome sequencing of the peripheral blood samples from different groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ctDNA test model for early screening of breast cancer |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ctDNA, early screening, Copy Number Variants (CNV), Low Depth Whole Genome Sequencing (LDWGS)