Status:
COMPLETED
Exploring a Breast Cancer Early Screening Model Based on cfDNA
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
OmixScience Institute
Conditions:
Breast Cancer
Breast Fibroadenoma
Eligibility:
All Genders
18-70 years
Brief Summary
The goal of this observational study is to use cfDNA multi-omics technology to explore a new breast cancer early detection model to improve the accuracy of early diagnosis in breast cancer patients. T...
Eligibility Criteria
Inclusion
- Patients ≥18 years old and ≤70 years old;
- Plasma of the participant can be obtained;
- Willing to sign the informed consent;
- Meet one of the following criteria:
- 1)Patients diagnosed with invasive breast cancer or carcinoma in situ of the breast for the first time; 4.2)Patients with breast fibroma or breast adenosis and breast fibrocystic hyperplasia;
Exclusion
- In any of the following situations, subjects should not participate in the trial:
- Pregnant or lactating;
- Unable to obtain the participant's plasma;
- Patients with other types of malignant tumors diagnosed by pathology within 5 years before enrollment;
- The patients had suspected imaging (B-ultrasound, CT, etc.) of other malignant tumors within the past 1 year after enrollment, but no pathological confirmation;
- Received any blood product transfusion in the past 30 days;
- Participants considered by the investigator to be inappropriate to participate in this research-type clinical trial.
Key Trial Info
Start Date :
April 11 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
839 Patients enrolled
Trial Details
Trial ID
NCT06016790
Start Date
April 11 2023
End Date
October 31 2024
Last Update
July 29 2025
Active Locations (8)
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1
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China, 233000
2
Affiliated Hangzhou First People's Hospital ,Westlake University School of Medicine
Hangzhou, Zhejiang, China, 310000
3
Sir Run Run Shaw Hospital Affiliated With Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
4
Wenhui Community Health Service center, Gongshu district, Hangzhou city
Hangzhou, Zhejiang, China, 310000