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

NCT ID: NCT04003558

Last Updated: 2019-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-28

Study Completion Date

2025-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Neoplasm Female Early-stage Breast Cancer Radiomics Axillary Lymph Node Survival, Prosthesis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions

Intervention Type OTHER

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.

No interventions

Intervention Type OTHER

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.

No interventions

Intervention Type OTHER

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.

No interventions

Intervention Type OTHER

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

Interventions

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No interventions

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role collaborator

Tungwah Hospital of Sun Yat-Sen University

UNKNOWN

Sponsor Role collaborator

Southern Medical University, China

OTHER

Sponsor Role collaborator

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Herui Yao

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Herui Yao, PhD

Role: STUDY_CHAIR

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

Chuanmiao Xie, PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Jie Ouyang, PhD

Role: PRINCIPAL_INVESTIGATOR

Tungwah Hospital of Sun Yat-Sen University

Qiugen Hu, PhD

Role: PRINCIPAL_INVESTIGATOR

Southern Medical University, China

Haotian Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Tungwah Hospital of Sun Yat-Sen University

Dongguan, Guangdong, China

Site Status NOT_YET_RECRUITING

Shunde hospital of southern medical university

Foshan, Guangdong, China

Site Status RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Herui Yao, PhD

Role: CONTACT

+8613500018020

Yunfang Yu, MD

Role: CONTACT

+8613660238987

Facility Contacts

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Jie Ouyang, PhD

Role: primary

+8613537479470

Qiugen Hu, PhD

Role: primary

+8613928206009

Chuanmiao Xie, PhD

Role: primary

+8618903050011

Haotian Lin, PhD

Role: primary

+8613802793086

Wenben Chen, MD

Role: backup

+8618819472798

Herui Yao, PhD

Role: primary

+8613500018020

References

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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.

Reference Type DERIVED
PMID: 34233259 (View on PubMed)

Other Identifiers

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SYSEC-KY-KS-2019-054-001

Identifier Type: -

Identifier Source: org_study_id

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