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出境医 / 临床实验 / MRI Radiomics Assessing Neoadjuvant Chemotherapy in Breast Cancer to Predict Lymph Node Metastasis and Prognosis(RBC-02) (RBC-02)
MRI Radiomics Assessing Neoadjuvant Chemotherapy in Breast Cancer to Predict Lymph Node Metastasis and Prognosis(RBC-02) (RBC-02)
Study Description
Brief Summary:
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Invasive Breast Cancer Neoadjuvant Chemotherapy Radiomics Axillary Lymph Node Prognosis | Other: No interventions |
Detailed Description:
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.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 600 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Novel Radiomics Signature on MRI Before and After Neoadjuvant Chemotherapy in Breast Cancer to Predict Axillary Lymph Node Metastasis and Prognosis (RBC-02) |
| Actual Study Start Date : | May 28, 2019 |
| Estimated Primary Completion Date : | October 30, 2020 |
| Estimated Study Completion Date : | May 30, 2025 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
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.
|
Other: No interventions
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.
|
Other: No interventions
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.
|
Other: No interventions
As this is a patient registry, there are no interventions.
|
Outcome Measures
Primary Outcome Measures :
- Disease free survival (DFS) [ Time Frame: 5 years ]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.
Secondary Outcome Measures :
- pathological complete response (pCR) [ Time Frame: Pathologic evaluation will be performed for each patient within 1 week after surgery ]The value of Radiomics of breast MRI in predicting responses to neoadjuvant chemotherapy, including reaching pCR and not reaching pCR.
- Pathological axillary lymph node status [ Time Frame: Pathologic evaluation will be performed for each patient within 1 week after surgery ]The value of Radiomics of breast MRI in predicting pathological axillary lymph node status is defined as axillary lymph node metastasis exists or not.
- Overall survival (OS) [ Time Frame: 5 years ]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.
- Breast cancer specific motality (BCSM) [ Time Frame: 5 years ]Defined as time between randomization and the time of death occur specific due to breast cancer
- Recurrence free survival (RFS) [ Time Frame: 5 years ]Defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Invasive breast cancer patients with no distant organ metastasis who had neoadjuvant chemotherapy before the surgery
Criteria
Inclusion Criteria:
- Primary lesion diagnosed as invasive breast cancer;
- Imaging examination confirmed no distant organ metastasis;
- Received neoadjuvant chemotherapy for drugs such as taxanes, anthracyclines, and platinum as planned;
- Completed breast MRI examination before or after neoadjuvant chemotherapy;
- Accepted breast cancer surgery and axillary lymph node dissection;
- Eastern Cooperative Oncology Group performance status 0-2.
Exclusion Criteria:
- History of ipsilateral axillary or breast surgery;
- Inflammatory breast cancer;
- Bilateral breast cancer;
- Malignant tumor history in 5 years;
- Patients with cervical or contralateral axillary lymph node metastasis;
- Incomplete imaging or medical history data.
Contacts and Locations
Contacts
| Contact: Herui Yao, Ph. D | +8613500018020 | yaoherui@mail.sysu.edu.cn | |
| Contact: Yunfang Yu, MD | +8613660238987 | yuyf9@mail.sysu.edu.cn |
Locations
| China, Guangdong | |
| Sun Yat-sen University Cancer Center | Recruiting |
| Guangzhou, Guangdong, China, 510000 | |
| Contact: Chuanmiao Xie, PhD +8618903050011 xiechm@sysucc.org.cn | |
| Principal Investigator: Chuanmiao Xie, PhD | |
| Sub-Investigator: Nian Lu, MD | |
| Zhongshan Ophthalmic Center, Sun Yat-Sen University | Not yet recruiting |
| Guangzhou, Guangdong, China, 510060 | |
| Contact: Haotian Lin, PhD +8613802793086 gddlht@aliyun.com | |
| Principal Investigator: Haotian Lin, PhD | |
| Sub-Investigator: Wenben Chen, MD | |
| Sun Yat-Sen Memorial Hospital of Sun Yat-sen University | Recruiting |
| Guangzhou, Guangdong, China, 510120 | |
| Contact: Herui Yao, PhD +8613500018020 yaoherui@mail.sysu.edu.cn | |
| Contact: Yunfang Yu, MD +8613660238987 yuyf9@mail.sysu.edu.cn | |
| Principal Investigator: Herui Yao, PhD | |
| Sub-Investigator: Yunfang Yu, MD | |
| Sub-Investigator: Chenchen Li, MD | |
| Sub-Investigator: Kai Chen, MD | |
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sun Yat-sen University
Tungwah Hospital of Sun Yat-Sen University
Investigators
| Study Chair: | Herui Yao, PhD | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | |
| Principal Investigator: | Chuanmiao Xie, PhD | Sun Yat-sen University | |
| Principal Investigator: | Haotian Lin, PhD | Zhongshan Ophthalmic Center, Sun Yat-sen University |
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 30, 2019 | |||||||||
| First Posted Date | July 2, 2019 | |||||||||
| Last Update Posted Date | June 29, 2020 | |||||||||
| Actual Study Start Date | May 28, 2019 | |||||||||
| Estimated Primary Completion Date | October 30, 2020 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
Disease free survival (DFS) [ Time Frame: 5 years ] 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.
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | MRI Radiomics Assessing Neoadjuvant Chemotherapy in Breast Cancer to Predict Lymph Node Metastasis and Prognosis(RBC-02) | |||||||||
| Official Title | Novel Radiomics Signature on MRI Before and After Neoadjuvant Chemotherapy in Breast Cancer to Predict Axillary Lymph Node Metastasis and Prognosis (RBC-02) | |||||||||
| Brief Summary | 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 | 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. | |||||||||
| Study Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | Invasive breast cancer patients with no distant organ metastasis who had neoadjuvant chemotherapy before the surgery | |||||||||
| Condition |
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| Intervention | Other: No interventions
As this is a patient registry, there are no interventions.
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| Study Groups/Cohorts |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Recruiting | |||||||||
| Estimated Enrollment |
600 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Estimated Study Completion Date | May 30, 2025 | |||||||||
| Estimated Primary Completion Date | October 30, 2020 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 75 Years (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts |
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| Listed Location Countries | China | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT04004559 | |||||||||
| Other Study ID Numbers | SYSEC-KY-KS-2019-055-001 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Herui Yao, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | |||||||||
| Study Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | |||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | |||||||||
| Verification Date | June 2020 | |||||||||
