Clinical Study of Glycosylated Extracellular Vesicles for Early Diagnosis of Breast Cancer

Peking University

Status: Enrolling

Conditions: Breast Cancer

Treatments: Diagnostic Test: Blood Sample

Study type: Observational

Funder types: Other

Identifiers

NCT05417048

BC-P31

Details and patient eligibility

About

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 detection of breast cancer.

Full 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 vesicles, one of the three major resources of liquid biopsy, contain multi-omics information that can be used to discover effective biomarkers for early diagnosis and screening of cancers.

In this study, we are going to isolate glycosylated extracellular vesicles from serum of cancer patients and non-cancer people with the novel GlyExo-Capture technology, and perform miRNA sequencing to selected out breast cancer-related markers. Then an early diagnosis model of breast cancer based on the GlyExo-Capture platform is able to be established using machine learning techniques and validated by qPCR experiments.

Enrollment: 420 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients≥18 years old；
2. 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)
3. Previous not received preoperative radiotherapy, chemotherapy, endocrine therapy, immunotherapy, or other anticancer treatments.
4. Subjects signed informed consent；

Exclusion criteria

1. A history of prior or concomitant malignancies;
2. advanced stage breast cancer (stage IV)；
3. Patients were accompanied by severe organic diseases such as heart and cerebral disease, and liver and kidney disease.；
4. Pregnant or lactating women ；
5. Suspected or confirmed lesion was surgically removed；
6. Patients with incomplete clinical data；
7. Patients with poor compliance；
8. Patients with severe mental illness；
9. Patients had received blood transfusions during one month一；

Trial design

420 participants in 3 patient groups

Breat cancer

Description:

Histologically confirmed breast cancer patients(Stage I-III)

Treatment:

Diagnostic Test: Blood Sample

Benign breast disease

Description:

Histologically confirmed breast fibroma, intraductal papilloma,mammary hyperplasia, breast cyst etc

Treatment:

Diagnostic Test: Blood Sample

Healthy control

Description:

No breast lesions detected by clinical examination/mammography/ultrasound/breast magnetic resonance imaging (MRI)

Treatment:

Diagnostic Test: Blood Sample