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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: Blood Sample

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.

• Study Type: Observational
• Enrollment (Anticipated): 420

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Peking University Cancer Hospital
      • Sub-Investigator: Xue Chen, MD
      • Sub-Investigator: Zhaorong Guo, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Breat cancer, Benign breast disease and Healthy control

Description

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；

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breat cancer; Histologically confirmed breast cancer patients(Stage I-III)	Diagnostic test: Blood Sample; Up to 5mL of blood via venipuncture
Benign breast disease; Histologically confirmed breast fibroma, intraductal papilloma,mammary hyperplasia, breast cyst etc	Diagnostic test: Blood Sample; Up to 5mL of blood via venipuncture
Healthy control; No breast lesions detected by clinical examination/mammography/ultrasound/breast magnetic resonance imaging (MRI)	Diagnostic test: Blood Sample; Up to 5mL of blood via venipuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Beijing Glyexo Gene Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Anticipated): December 15, 2023
• Study Completion (Anticipated): June 15, 2024

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: BC-P31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No