NCT04535466

Brief Summary

It is a prospective, observational cohort study of patients with dense breast tissue. The study was based on the radiomics and other clinicopathological information of patients to establish the diagnostic system for breast disease by using artificial intelligence.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

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

August 21, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2020

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

Same day

First QC Date

August 21, 2020

Last Update Submit

August 31, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • the predictive model's area under curve(AUC)

    To assess the predictive accuracy of the radiomic-based and clinical-based model by using operating characteristic curve (ROC) analysis and calculating the area under the curves (AUC).

    follow up for 2 year for individuals

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female patients aged 18-80 were included in our study who were diagnosed and treated at Sun Yat-sen memorial hospital .

You may qualify if:

  • Female patients with dense breast density tissue
  • Digital breast tomosynthesis was performed
  • Breast ultrasound examination was performed
  • Pathologic examination of breast lesions was performed

You may not qualify if:

  • Incomplete clinicopathologic data
  • Female patients with fatty glands of the breast

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Breast tumor center of Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Breast Diseases

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Yaping Yang, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 21, 2020

First Posted

September 2, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

September 2, 2020

Record last verified: 2020-08

Locations