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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04003558
Other study ID # SYSEC-KY-KS-2019-054-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 28, 2019
Est. completion date January 1, 2025

Study information

Verified date August 2019
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact Herui Yao, PhD
Phone +8613500018020
Email yaoherui@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date January 1, 2025
Est. primary completion date May 31, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
China Tungwah Hospital of Sun Yat-Sen University Dongguan Guangdong
China Shunde hospital of southern medical university Foshan Guangdong
China Sun Yat-Sen Memorial Hospital of Sun Yat-sen University Guangzhou Guangdong
China Sun Yat-sen University Cancer Center Guangzhou Guangdong
China Zhongshan Ophthalmic Center, Sun Yat-Sen University Guangzhou Guangdong

Sponsors (5)

Lead Sponsor Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Shunde Hospital of Southern Medical University, Sun Yat-sen University, Tungwah Hospital of Sun Yat-Sen University, Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The correlation of radiomics features and tumor microenvironment Radiomics is a tool to analyze tumor microenvironment characteristics based on breast MRI images. baseline (Completed MRI data before biopsy,surgery,neoadjuvant and radiotherapy.)
Secondary Lymph node metastasis The value of Radiomics of multiparametric MRI in predicting axillary lymph node metastasis. Baseline
Secondary Overall survival (OS) 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
Secondary Beast cancer specific motality (BCSM) Defined as time between randomization and the time of death occur specific due to breast cancer 5 years
Secondary Recurrence free survival (RFS) 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
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