Application of Radiomics in Breast Cancer | NCT04483804

Studies
Application of Radiomics in Breast Cancer

NCT04483804

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Recruiting

Last Update Posted

Mar 10, 2023Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Breast Cancer
Ultrasound
Elastography
Pathology
Radiomics

Interventions

Endocrine therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

May 13, 2020

First Submission Date that Met QC Criteria

Jul 20, 2020

First Posted Date

Jul 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2023

Last Update Posted Date

Mar 10, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Endocrine therapy	Combination Product	Endocrine therapy	disease free survival non-disease free survival

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of breast cancer

Exclusion Criteria:

Missing pathology Missing follow-up results Missing data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Female dominated

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients with breast cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
zimei Lin	Contact	+8615157171799		zimei.lin@zju.edu.cn
jifan Chen	Contact	+8613605771565		jifanchen@zju.edu.cn

Overall Officials

Name	Affiliation	Role
pintong Huang	Second Affiliated Hospital, School of Medicine, Zhejiang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the Second Affiliated Hospital Zhejiang University School of Medicine	Recruiting	Hanzhou	Zhejiang	310009	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

by request

Access Criteria

by request

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided