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

Breast Cancer Clinical Trial

Official title:

miRNAs of Circulating Glycosylated Extracellular Vesicles as Biomarkers for Early Diagnosis of Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05417048
• Other study ID #: BC-P31
• Status: Recruiting
• Start date: July 14, 2022
• Est. completion date: June 15, 2024

Study information

• Verified date: February 2023
• Source: Peking University
• Contact: Zhaoqing Fan, MD
• Phone: +86-10-88197838
• Email: zhqfan[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 detection of breast cancer.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: June 15, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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?;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• Blood Sample
Up to 5mL of blood via venipuncture

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Beijing Glyexo Gene Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic performance of the blood assay for differentiating benign and malignant breast disease using glycosylated extracellular vesicles analysis	The efficacy of the blood-based assay comparing with patholgic diagnosis, the gold standard, and imaging diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)	24 months