Deep Learning Algorithms for Prediction of Lymph Node Metastasis and Prognosis in Breast Cancer MRI Radiomics (RBC-01)

August 13, 2019 updated by: Herui Yao, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Sensitivity for prediction of lymph node metastasis and survival of currently available prognostic scores in limited. This study proposes to establish a deep learning algorithms of multiparametric MRI radiomics and nomogram for identifying lymph node metastasis and prognostic prediction of breast cancer. The study will investigate the relationship between the radiomics and the tumor microenvironment. The study includes the construction of multiparametric MRI radiomics-based prediction model and the validation of the prediction model.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Dongguan, Guangdong, China, 523000
        • Not yet recruiting
        • Tungwah Hospital of Sun Yat-Sen University
        • Contact:
        • Principal Investigator:
          • Jie Ouyang, PhD
      • Foshan, Guangdong, China, 528300
        • Recruiting
        • Shunde Hospital of Southern Medical University
        • Contact:
        • Principal Investigator:
          • Qiugen Hu, PhD
        • Sub-Investigator:
          • Xiaohong Li, MD
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Chuanmiao Xie, PhD
        • Sub-Investigator:
          • Nian Lu, MD
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • Contact:
        • Sub-Investigator:
          • Yufang Yu, MD
        • Sub-Investigator:
          • Yujie Tan, MD
        • Sub-Investigator:
          • Kai Chen, MD
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Wenben Chen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
As this is a patient registry, there are no interventions.
Sun Yat-sen University Cancer Center
The cohort of Sun Yat-sen University Cancer Center is a validation cohort.
Other: No interventions
As this is a patient registry, there are 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
As this is a patient registry, there are no interventions.
Shunde hospital of southern medical university
The cohort of Shunde hospital of southern medical university is a validation cohort.
Other: No interventions
As this is a patient registry, there are no interventions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease free survival (DFS)
Time Frame: 5 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The correlation of radiomics features and tumor microenvironment
Time Frame: baseline (Completed MRI data before biopsy,surgery,neoadjuvant and radiotherapy.)
Radiomics is a tool to analyze tumor microenvironment characteristics based on breast MRI images.
baseline (Completed MRI data before biopsy,surgery,neoadjuvant and radiotherapy.)
Lymph node metastasis
Time Frame: Baseline
The value of Radiomics of multiparametric MRI in predicting axillary lymph node metastasis.
Baseline
Overall survival (OS)
Time Frame: 5 years
The association between Radiomics of multiparametric MRI and overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes.
5 years
Beast cancer specific motality (BCSM)
Time Frame: 5 years
Defined as time between randomization and the time of death occur specific due to breast cancer
5 years
Recurrence free survival (RFS)
Time Frame: 5 years
defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sun Yat-sen University
Zhongshan Ophthalmic Center, Sun Yat-sen University
Southern Medical University, China
Tungwah Hospital of Sun Yat-Sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SYSEC-KY-KS-2019-054-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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