NCT04004559

Brief Summary

This study is aimed to illustrate whether Radiomics combining multiparametric MRI before and after neoadjuvant chemotherapy (NACT) with clinical data is a good way to predict axillary lymph node metastasis and prognosis in invasive-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
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

3 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
1 month until next milestone

First Submitted

Initial submission to the registry

June 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

1.4 years

First QC Date

June 30, 2019

Last Update Submit

June 25, 2020

Conditions

Invasive Breast CancerNeoadjuvant ChemotherapyRadiomicsAxillary Lymph NodePrognosis

Keywords

Invasive Breast CancerNeoadjuvant ChemotherapyRadiomicsAxillary Lymph Node MetastasisSurvivalMachine Learning Analysis

Outcome Measures

Primary Outcomes (1)

  • Disease free survival (DFS)

    The association between Radiomics of multiparametric MRI and 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)

  • pathological complete response (pCR)

    Pathologic evaluation will be performed for each patient within 1 week after surgery

  • Pathological axillary lymph node status

    Pathologic evaluation will be performed for each patient within 1 week after surgery

  • Overall survival (OS)

    5 years

  • Breast cancer specific motality (BCSM)

    5 years

  • Recurrence free survival (RFS)

    5 years

Study Arms (3)

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

Cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is the training cohort.

Other: No interventions

Sun Yat-sen University Cancer Center

Cohort of Sun Yat-sen University Cancer Center is validation cohort 1.

Other: No interventions

Tungwah Hospital of Sun Yat-Sen University

Cohort of Tungwah Hospital of Sun Yat-Sen University is validation cohort 2.

Other: No interventions

Interventions

No interventionsOTHER

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

Sun 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

Invasive breast cancer patients with no distant organ metastasis who had neoadjuvant chemotherapy before the surgery

You may qualify if:

  • Primary lesion diagnosed as invasive breast cancer;
  • Imaging examination confirmed no distant organ metastasis;
  • Received neoadjuvant chemotherapy for drugs such as taxanes, anthracyclines, and platinum as planned;
  • Completed breast MRI examination before or after neoadjuvant chemotherapy;
  • Accepted breast cancer surgery and axillary lymph node dissection;
  • Eastern Cooperative Oncology Group performance status 0-2.

You may not qualify if:

  • History of ipsilateral axillary or breast surgery;
  • Inflammatory breast cancer;
  • Bilateral breast cancer;
  • Malignant tumor history in 5 years;
  • Patients with cervical or contralateral axillary lymph node metastasis;
  • Incomplete imaging or medical history data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

NOT YET RECRUITING

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

Guangzhou, Guangdong, 510120, China

RECRUITING

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

  • Haotian Lin, PhD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Herui Yao, Ph. D

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 Investigation

Study Record Dates

First Submitted

June 30, 2019

First Posted

July 2, 2019

Study Start

May 28, 2019

Primary Completion

October 30, 2020

Study Completion

May 30, 2025

Last Updated

June 29, 2020

Record last verified: 2020-06

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(3)