NCT05417048

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 420 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood Sample	Up to 5mL of blood via venipuncture

Timeline

• Start date: 2022-07-14
• Primary completion: 2023-12-15
• Completion: 2024-06-15
• First posted: 2022-06-14
• Last updated: 2023-02-23

Locations

1 site across 1 country: China