Application of Radiomics in Breast Cancer

Application of Radiomics in Correlation Between Ultrasound Characteristics and Pathological Prognostic Factors in Breast Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Elastography; Ultrasound; Radiomics; Pathology
• Intervention / Treatment: Combination product: Endocrine therapy

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: zimei Lin; Phone Number: +8615157171799; Email: zimei.lin@zju.edu.cn
• Study Contact Backup: Name: jifan Chen; Phone Number: +8613605771565; Email: jifanchen@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hanzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: jifan Chen; Phone Number: +8613605771565; Email: jifanchen@zju.edu.cn
      • Contact: zimei Lin; Phone Number: +86151517171799; Email: zimei.lin@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with breast cancer

Description

Inclusion Criteria:

Clinical diagnosis of breast cancer

Exclusion Criteria:

Missing pathology Missing follow-up results Missing data

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
disease free survival; Time from randomization to relapse or death due to disease progression	Combination product: Endocrine therapy; Endocrine therapy
non-disease free survival; Time of metastasis or death	Combination product: Endocrine therapy; Endocrine therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Pintong Huang, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2028

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SAHZhejiangU---Breast

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: individual participant data (IPD) can be shared after the main unit publish articles
• IPD Sharing Time Frame: by request
• IPD Sharing Access Criteria: by request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No