NCT04483804

Brief Summary

Little is known about the correlation between ultrasound characteristics (conventional, elastography and contrast enhanced ultrasound (CEUS) )and pathological prognostic factors in breast cancer. The aim of this study was to explore the correlation between ultrasound characteristics and pathological prognostic factors using radiomics.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress76%
Jan 2018Dec 2028

Study Start

First participant enrolled

January 1, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Expected
Last Updated

March 10, 2023

Status Verified

December 1, 2022

Enrollment Period

5.9 years

First QC Date

May 13, 2020

Last Update Submit

March 9, 2023

Conditions

Breast CancerUltrasoundElastographyPathologyRadiomics

Outcome Measures

Primary Outcomes (2)

  • metastasis

    lymph node metastasis and/or distant metastasis

    through study completion, an average of 1 year

  • death

    death

    through study completion, an average of 1 year

Study Arms (2)

disease free survival

Time from randomization to relapse or death due to disease progression

Combination Product: Endocrine therapy

non-disease free survival

Time of metastasis or death

Combination Product: Endocrine therapy

Interventions

Endocrine therapyCOMBINATION_PRODUCT

Endocrine therapy

disease free survivalnon-disease free survival

Eligibility Criteria

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

patients with breast cancer

You may qualify if:

  • Clinical diagnosis of breast cancer

You may not qualify if:

  • Missing pathology Missing follow-up results Missing data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Second Affiliated Hospital Zhejiang University School of Medicine

Hanzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • pintong Huang

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

zimei Lin

CONTACT

+8615157171799zimei.lin@zju.edu.cn

jifan Chen

CONTACT

+8613605771565jifanchen@zju.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2020

First Posted

July 23, 2020

Study Start

January 1, 2018

Primary Completion

December 1, 2023

Study Completion (Estimated)

December 1, 2028

Last Updated

March 10, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

individual participant data (IPD) can be shared after the main unit publish articles

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
by request
Access Criteria
by request

Locations

CN(1)