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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Blood Sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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；

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 |