Status:
ACTIVE_NOT_RECRUITING
PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale BREAST Cancers, PERCEIVE-BREAST
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsors:
Guangzhou Bruning Rock Bioengineering Ltd
Conditions:
Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
This study is a retrospective and prospective study aimed to develop and validate the performance of multi-omics assays for early detection of female breast cancer. The study will enroll approximately...
Eligibility Criteria
Inclusion
- Inclusion Criteria for All Participants:
- Able to provide a written informed consent.
- Female, at least 18 years old.
- Additional Inclusion Criteria for Breast Cancer Participants:
- Pathologically confirmed breast cancer diagnosis or highly suspicious for breast cancer within 42 days prior to blood draw.
- No prior cancer treatment before the blood draw.
- Additional Inclusion Criteria for Breast Benign Disease Participants:
- Pathologically confirmed breast cancer diagnosis or highly suspicious of breast benign diseases within 90 days prior to blood draw.
- No prior radical treatment before the blood draw.
- Exclusion Criteria for All Participants:
- During pregnancy or lactation.
- Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
- Recipient of blood transfusion within 7 days prior to blood draw.
- Recipient of anti-tumor drugs to treat non-cancer diseases prior to blood draw, such as rheumatic drugs (methotrexate, cyclophosphamide, or azathioprine), or endocrine drugs (tamoxifen).
- Additional Exclusion Criteria for Breast Cancer Participants:
- Multiple primary tumors.
Exclusion
Key Trial Info
Start Date :
July 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2026
Estimated Enrollment :
496 Patients enrolled
Trial Details
Trial ID
NCT06979921
Start Date
July 10 2021
End Date
December 30 2026
Last Update
August 14 2025
Active Locations (2)
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1
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
2
The Affiliated Hospital of Medical College Qingdao University
Qingdao, Shandong, China, 266100