NCT04003558

Brief Summary

This bi-directional, multicentre study aims to assess multiparametric MRI Radiomics-based prediction model for identifying metastasis lymph nodes and prognostic prediction in breast cancer.

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
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

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

May 28, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

June 26, 2019

Last Update Submit

August 13, 2019

Conditions

Breast Neoplasm FemaleEarly-stage Breast CancerRadiomicsAxillary Lymph NodeSurvival, Prosthesis

Keywords

Early-stage Breast CancerRadiomicsAxillary lymph node metastasisTumor microenvironmentSurvivalDeep learning

Outcome Measures

Primary Outcomes (1)

  • Disease free survival (DFS)

    Disease free survival (DFS), which defined as the time from the diagnosis of breast cancer to the confirmed time of metastatic disease, or death due to any other cause.

    5 years

Secondary Outcomes (5)

  • The correlation of radiomics features and tumor microenvironment

    baseline (Completed MRI data before biopsy,surgery,neoadjuvant and radiotherapy.)

  • Lymph node metastasis

    Baseline

  • Overall survival (OS)

    5 years

  • Beast cancer specific motality (BCSM)

    5 years

  • Recurrence free survival (RFS)

    5 years

Study Arms (4)

Sun Yat-Sen Memorial Hospital of Sun Yat-sen University

The cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is a training cohort.

Other: No interventions

Sun Yat-sen University Cancer Center

The cohort of Sun Yat-sen University Cancer Center is a validation cohort.

Other: No interventions

Tungwah Hospital of Sun Yat-Sen University

The cohort of Tungwah Hospital of Sun Yat-Sen University is a validation cohort.

Other: No interventions

Shunde hospital of southern medical university

The cohort of Shunde hospital of southern medical university is a validation cohort.

Other: No interventions

Interventions

No interventionsOTHER

As this is a patient registry, there are no interventions.

Shunde hospital of southern medical universitySun Yat-Sen Memorial Hospital of Sun Yat-sen UniversitySun Yat-sen University Cancer CenterTungwah Hospital of Sun Yat-Sen University

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who had early stage breast cancer and completed the breast MRI examination before operation,lymph node biopsy,neoadjuvant chemotherapy,and radiotherapy.

You may qualify if:

  • The primary lesion was diagnosed as invasive breast cancer
  • Patients can have regional lymph node metastasis,but no distant organ metastasis
  • Complete the breast MRI examination before treatment
  • Accept breast cancer surgery or lymph node biopsy
  • Eastern Cooperative Oncology Group performance status 0-2

You may not qualify if:

  • Inflammatory breast cancer
  • Accompanied with other primary malignant tumors
  • Perform surgery,radiotherapy and lymph node biopsy before breast MRI examination
  • Patients who have neoadjuvant chemotherapy
  • Patients had distant and contralateral axillary lymph node metastasis
  • The pathologic diagnosis was extensive ductal carcinoma in situ

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Tungwah Hospital of Sun Yat-Sen University

Dongguan, Guangdong, 523000, China

NOT YET RECRUITING

Shunde hospital of southern medical university

Foshan, Guangdong, 528300, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

Sun Yat-Sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (1)

  • Yu Y, He Z, Ouyang J, Tan Y, Chen Y, Gu Y, Mao L, Ren W, Wang J, Lin L, Wu Z, Liu J, Ou Q, Hu Q, Li A, Chen K, Li C, Lu N, Li X, Su F, Liu Q, Xie C, Yao H. Magnetic resonance imaging radiomics predicts preoperative axillary lymph node metastasis to support surgical decisions and is associated with tumor microenvironment in invasive breast cancer: A machine learning, multicenter study. EBioMedicine. 2021 Jul;69:103460. doi: 10.1016/j.ebiom.2021.103460. Epub 2021 Jul 4.

    PMID: 34233259DERIVED

MeSH Terms

Conditions

Breast NeoplasmsProsthesis Failure

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Herui Yao, PhD

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    STUDY CHAIR

  • Chuanmiao Xie, PhD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Jie Ouyang, PhD

    Tungwah Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

  • Qiugen Hu, PhD

    Southern Medical University, China

    PRINCIPAL INVESTIGATOR

  • Haotian Lin, PhD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Herui Yao, PhD

CONTACT

+8613500018020yaoherui@mail.sysu.edu.cn

Yunfang Yu, MD

CONTACT

+8613660238987yuyf9@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 26, 2019

First Posted

July 1, 2019

Study Start

May 28, 2019

Primary Completion

May 31, 2020

Study Completion

January 1, 2025

Last Updated

August 15, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Requests for the individual data or study documents will be considered where the proposed use aligns with public good purposes, does not conflict with other requests, and the requestor is willing to sign a data access agreement. Contact is though the corresponding author.

Locations

CN(5)