NCT04929054

Brief Summary

The aim of this study was to investigate the added value of Principal Component Regression (PCR) based 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
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 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

April 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
10 months 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

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

July 15, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

April 7, 2021

Last Update Submit

July 13, 2021

Conditions

PCABreast Cancer

Outcome Measures

Primary Outcomes (1)

  • surgery or biopsy

    According to the PCR result, if it's positive, the nodule category was maintained, however, if it's negative, the nodule was downgraded. all nodules were submitted to biopsy or biopsy.

    up to 3 months

Interventions

imagingDIAGNOSTIC_TEST

ultrasound and contrast enhanced ultrasound for BI RADS4A breast modules

Also known as: in-vitro

Eligibility Criteria

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

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

You may qualify if:

  • patients with BI-RADS 4A 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

Location

Biospecimen

Retention: SAMPLES WITH DNA

pathology results of breast nodules

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diagnostic ImagingIn Vitro Meat

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisMeatFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • pintong Huang

    SAHZJU

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

April 7, 2021

First Posted

June 18, 2021

Study Start

April 1, 2019

Primary Completion

May 30, 2020

Study Completion

December 30, 2021

Last Updated

July 15, 2021

Record last verified: 2021-03

Locations

CN(1)