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| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
| Tungwah Hospital of Sun Yat-Sen University | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Sun Yat-sen University Cancer Center | Cohort of Sun Yat-sen University Cancer Center is validation cohort 1. |
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| Tungwah Hospital of Sun Yat-Sen University | Cohort of Tungwah Hospital of Sun Yat-Sen University is validation cohort 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No interventions | Other | As this is a patient registry, there are no interventions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival (DFS) | The association between Radiomics of multiparametric MRI and 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 |
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response (pCR) | The value of Radiomics of breast MRI in predicting responses to neoadjuvant chemotherapy, including reaching pCR and not reaching pCR. | Pathologic evaluation will be performed for each patient within 1 week after surgery |
| Pathological axillary lymph node status |
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Inclusion Criteria:
Exclusion Criteria:
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Invasive breast cancer patients with no distant organ metastasis who had neoadjuvant chemotherapy before the surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Herui Yao, Ph. D | Contact | +8613500018020 | yaoherui@mail.sysu.edu.cn | |
| Yunfang Yu, MD | Contact | +8613660238987 | yuyf9@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Herui Yao, PhD | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Study Chair |
| Chuanmiao Xie, PhD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510000 | China |
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.
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The value of Radiomics of breast MRI in predicting pathological axillary lymph node status is defined as axillary lymph node metastasis exists or not. |
| Pathologic evaluation will be performed for each patient within 1 week after surgery |
| 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 |
| Breast cancer specific motality (BCSM) | Defined as time between randomization and the time of death occur specific due to breast cancer | 5 years |
| 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 |
| Haotian Lin, PhD |
| Zhongshan Ophthalmic Center, Sun Yat-sen University |
| Principal Investigator |
| Zhongshan Ophthalmic Center, Sun Yat-Sen University | Not yet recruiting | Guangzhou | Guangdong | 510060 | China |
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| Sun Yat-Sen Memorial Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510120 | China |
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