Breast Cancer Clinical Trial
Official title:
miRNAs of Circulating Glycosylated Extracellular Vesicles as Biomarkers for Early Diagnosis of Breast Cancer Patients
NCT number | NCT05417048 |
Other study ID # | BC-P31 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 14, 2022 |
Est. completion date | June 15, 2024 |
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.
Status | Recruiting |
Enrollment | 420 |
Est. completion date | June 15, 2024 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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?; |
Country | Name | City | State |
---|---|---|---|
China | Peking University Cancer Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University | Beijing Glyexo Gene Technology Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Recruiting |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |