MRI Radiomics Assessing Neoadjuvant Chemotherapy in Breast Cancer to Predict Lymph Node Metastasis and Prognosis(RBC-02)

NCT ID: NCT04004559

Last Updated: 2020-06-29

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

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-28

Study Completion Date

2025-05-30

Brief Summary

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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.

Detailed Description

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This study proposes to build a clinical predictive model to predict axillary lymph node metastasis and prognosis in invasive-breast-cancer patients who received neoadjuvant chemotherapy before surgery. The model is built based on breast MRI signatures extracted and analyzed via deep machine-learning algorithm methods. Invasive breast cancer patients undergo multiparametric MRI at baseline, then undergo multiparametric MRI after received neoadjuvant chemotherapy for at least 4 cycles as planned. After the surgery, responses to neoadjuvant chemotherapy are determined according to the histopathologically examination of the surgically resected specimens. After completion of treatment procedure, patients are followed up for 5 years.

Conditions

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Invasive Breast Cancer Neoadjuvant Chemotherapy Radiomics Axillary Lymph Node Prognosis

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

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

No interventions

Intervention Type OTHER

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

Sun Yat-sen University Cancer Center

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

No interventions

Intervention Type OTHER

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

Tungwah Hospital of Sun Yat-Sen University

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

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

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

Exclusion Criteria

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

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

OTHER

Sponsor Role lead

Responsible Party

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Herui Yao

Principal Investigation

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

Haotian Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status 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, Ph. D

Role: CONTACT

+8613500018020

Yunfang Yu, MD

Role: CONTACT

+8613660238987

Facility Contacts

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Chuanmiao Xie, PhD

Role: primary

+8618903050011

Haotian Lin, PhD

Role: primary

+8613802793086

Herui Yao, PhD

Role: primary

+8613500018020

Yunfang Yu, MD

Role: backup

+8613660238987

Other Identifiers

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SYSEC-KY-KS-2019-055-001

Identifier Type: -

Identifier Source: org_study_id

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