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
Study Overview
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100142
- Recruiting
- Peking University Cancer Hospital
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Sub-Investigator:
- Xue Chen, MD
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Sub-Investigator:
- Zhaorong Guo, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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；
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Breat cancer
Histologically confirmed breast cancer patients(Stage I-III)
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Up to 5mL of blood via venipuncture
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|
Benign breast disease
Histologically confirmed breast fibroma, intraductal papilloma,mammary hyperplasia, breast cyst etc
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Up to 5mL of blood via venipuncture
|
|
Healthy control
No breast lesions detected by clinical examination/mammography/ultrasound/breast magnetic resonance imaging (MRI)
|
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
Time Frame: 24 months
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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)
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24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC-P31
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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