NCT04929132

Brief Summary

The aim of this study was to investigate the added value of contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS).

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

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

Study Start

First participant enrolled

January 1, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 18, 2021

Status Verified

December 1, 2020

Enrollment Period

3 years

First QC Date

April 7, 2021

Last Update Submit

June 9, 2021

Conditions

UltrasoundBreast CancerPathology

Outcome Measures

Primary Outcomes (1)

  • CEUS

    if the result of CEUS is positive，the nodule was downgraded. if the result of CEUS is negative, the nodule was kept as BI RADS 4A category. Then all nodules were submitted to biopsy or surgery.

    up to 3 months

Eligibility Criteria

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

patients with nodules which were sonographically classified as BI-RADS 4 A breast lesion

You may qualify if:

  • patients with nodules which were sonographically classified as BI-RADS 4 A breast lesion

You may not qualify if:

  • (i) absence of a pathologic diagnosis; (ii) presence of breast nodules that were too large to compare with normal parenchyma; (iii) patients with radiotherapy and chemotherapy of breast cancer; and (iv) skin disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SAHZJU

Hanzhou, Zhejiang, 310009, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

pathology results of breast nodules

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

zimei Lin

CONTACT

15157171799kelaidia@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2021

First Posted

June 18, 2021

Study Start

January 1, 2019

Primary Completion

December 30, 2021

Study Completion

December 31, 2021

Last Updated

June 18, 2021

Record last verified: 2020-12

Locations

CN(1)