Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Lymphatic Metastasis

Prosthesis Failure

Breast Diseases

Skin Diseases

Neoplastic Processes

Postoperative Complications

The cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is a training cohort.

The cohort of Sun Yat-sen University Cancer Center is a validation cohort.

The cohort of Tungwah Hospital of Sun Yat-Sen University is a validation cohort.

The cohort of Shunde hospital of southern medical university is a validation cohort.

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

No interventions

Herui Yao, PhD

Yunfang Yu, MD

Jie Ouyang, PhD

Qiugen Hu, PhD

Xiaohong Li, MD

Chuanmiao Xie, PhD

Nian Lu, MD

Haotian Lin, PhD

Wenben Chen, MD

Yufang Yu, MD

Yujie Tan, MD

Kai Chen, MD

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.

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.

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

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.

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.

Radiomics is a tool to analyze tumor microenvironment characteristics based on breast MRI images.

The value of Radiomics of multiparametric MRI in predicting axillary lymph node metastasis.

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.

Defined as time between randomization and the time of death occur specific due to breast cancer

defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred

Sun Yat-sen University

Tungwah Hospital of Sun Yat-Sen University

Southern Medical University, China

Zhongshan Ophthalmic Center, Sun Yat-sen University

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

Principal Investigator

Serum osteopontin (OPN) was measured by ELIZA and osteopontin gene mutation was analyzed by sequencing and correlated with clinicopathological criteria, response, PFS and OS.

Osteopontin

Mohamed A Elbaiomy

OPN plays an important role in various aspects of malignancy, particularly those involved in tissue invasion and metastasis, and OPN levels have been associated with aggressive¬ness in several cancer types, including breast cancer. Tumor response to treatment is a predictor of prognosis and overall survival for cancer patient population the investigators assigned osteopontin as potential contributors in breast cancer.

Analysis of polymorphisms in the OPN regulatory region:

The PCR amplification of the promoter regulatory region from the extracted DNA by using the following primers -3 (forward primer 5" -CAA GCT ACT GCA TAC TCG AAA TCA CA-3" ; reverse primer 5" - ACA ACC AAG CCC TCC CAG AAT TTA-3" ). PCR was performed using 50 ng DNA as a template under the following conditions: 95°C for 10 min, then 36 cycles of 94°C for 30 s, an annealing temperature for 60 s, and 72°C for 60 s, with a final extension at 72°C for 15 min. After affinity membrane purification using the QIAquick Gel Extraction kit (Qiagen, Carlsbad, CA, USA), the PCR products were subjected to cycle sequencing with the respective forward and reverse primer using an automated ABI 310 DNA sequencer.

Measurement of serum level of osteopontin:

OPN level were measured using Enzyme linked immnosorbent (ELISA) Kit supplied by IBL (Immuno-Biological laboratories Co. Ltd., Japan). 30 normal females were conducted with matched age with a median osteopontine serum level of 15 so, this level was assigned as a cut off value.

Pretreatment serum level and polymorphism of oteopontine was correlated with different clinicopathological criteria of the patients, response to the treatment, PFS and OS.

The PCR amplification of the promoter regulatory region from the extracted DNA by using the following primers -3 (forward primer 5" -CAA GCT ACT GCA TAC TCG AAA TCA CA-3" ; reverse primer 5" - ACA ACC AAG CCC TCC CAG AAT TTA-3" ). PCR was performed using 50 ng DNA as a template under the following conditions: 95°C for 10 min, then 36 cycles of 94°C for 30 s, an annealing temperature for 60 s, and 72°C for 60 s, with a final extension at 72°C for 15 min. After affinity membrane purification using the QIAquick Gel Extraction kit (Qiagen, Carlsbad, CA, USA), the PCR products were subjected to cycle sequencing with the respective forward and reverse primer using an automated ABI 310 DNA sequencer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Deep Learning Algorithms for Prediction of Lymph Node Metastasis and Prognosis in Breast Cancer MRI Radiomics (RBC-01)	NCT04003558	Breast Neoplasm... Early-stage Bre... Radiomics Axillary Lymph ... Survival, Prost...	No intervention...	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Osteopontin in Metastatic Breast Cancer Patients	NCT04274504	Survival, Prost...	Osteopontin	31 Years - 74 Years	Mansoura University
Deep Learning Algorithms for Prediction of Lymph Node Metastasis and Prognosis in Breast Cancer MRI Radiomics (RBC-01)	NCT04003558	Breast Neoplasm... Early-stage Bre... Radiomics Axillary Lymph ... Survival, Prost...	No intervention...	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Osteopontin in Metastatic Breast Cancer Patients	NCT04274504	Survival, Prost...	Osteopontin	31 Years - 74 Years	Mansoura University
Osteopontin in Metastatic Breast Cancer Patients	NCT04274504	Survival, Prost...	Osteopontin	31 Years - 74 Years	Mansoura University
Osteopontin in Metastatic Breast Cancer Patients	NCT04274504	Survival, Prost...	Osteopontin	31 Years - 74 Years	Mansoura University

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