NCT05417048

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
420

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

July 14, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

June 6, 2022

Last Update Submit

February 22, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Breat cancer

Histologically confirmed breast cancer patients(Stage I-III)

Diagnostic Test: Blood Sample

Benign breast disease

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

Diagnostic Test: Blood Sample

Healthy control

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

Diagnostic Test: Blood Sample

Interventions

Blood SampleDIAGNOSTIC_TEST

Up to 5mL of blood via venipuncture

Benign breast diseaseBreat cancerHealthy control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Breat cancer, Benign breast disease and Healthy control

You may qualify if:

  • 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；

You may not qualify if:

  • 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；

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collection of blood of patients before treatment

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Zhaoqing Fan, MD

    Breast center at Peking University Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaoqing Fan, MD

CONTACT

+86-10-88197838zhqfan@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Breast Center of Peking University Cancer Hospital

Study Record Dates

First Submitted

June 6, 2022

First Posted

June 14, 2022

Study Start

July 14, 2022

Primary Completion

December 15, 2023

Study Completion

June 15, 2024

Last Updated

February 23, 2023

Record last verified: 2023-02

Locations

CN(1)