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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-14

Study Completion Date

2024-06-15

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.

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breat cancer

Histologically confirmed breast cancer patients(Stage I-III)

Blood Sample

Intervention Type DIAGNOSTIC_TEST

Up to 5mL of blood via venipuncture

Benign breast disease

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

Blood Sample

Intervention Type DIAGNOSTIC_TEST

Up to 5mL of blood via venipuncture

Healthy control

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

Blood Sample

Intervention Type DIAGNOSTIC_TEST

Up to 5mL of blood via venipuncture

Interventions

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Blood Sample

Up to 5mL of blood via venipuncture

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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；

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes