Status:
UNKNOWN
Clinical Study of Glycosylated Extracellular Vesicles for Early Diagnosis of Breast Cancer
Lead Sponsor:
Peking University
Collaborating Sponsors:
Beijing Glyexo Gene Technology Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
This is a prospective, single-center, non-randomized, cohort study designed to evaluate the clinical diagnostic performance of glycosylated extracellular vesicles and their contents for early detectio...
Detailed Description
Early screening technology can improve the survival rate of breast cancer patients. Traditional mammography and ultrasonography have limitations on performance in clinical practice. Extracellular vesi...
Eligibility Criteria
Inclusion
- Patients≥18 years old；
- Histologically confirmed breast cancer patients，Benign breast disease （ig. breast fibroma, intraductal papilloma,mammary hyperplasia, breast cyst）or No breast lesions detected by clinical examination/mammography/ultrasound/breast magnetic resonance imaging (MRI)
- Previous not received preoperative radiotherapy, chemotherapy, endocrine therapy, immunotherapy, or other anticancer treatments.
- Subjects signed informed consent；
Exclusion
- A history of prior or concomitant malignancies;
- advanced stage breast cancer (stage IV)；
- Patients were accompanied by severe organic diseases such as heart and cerebral disease, and liver and kidney disease.；
- Pregnant or lactating women ；
- Suspected or confirmed lesion was surgically removed；
- Patients with incomplete clinical data；
- Patients with poor compliance；
- Patients with severe mental illness；
- Patients had received blood transfusions during one month一；
Key Trial Info
Start Date :
July 14 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 15 2024
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT05417048
Start Date
July 14 2022
End Date
June 15 2024
Last Update
February 23 2023
Active Locations (1)
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1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142