About this trial
Breast cancer is a malignant tumor with the highest morbidity and mortality among women worldwide. Accurate staging of axillary lymph nodes is critical for metastatic assessment and decisions regarding treatment modalities in breast cancer patient. Among patients who underwent sentinel lymph node biopsy, about 70 % of the patients had negative pathological results and in other words, these 70 % of the patients received unnecessary surgery. At present, imaging and pathological diagnosis is the main measure of lymph node metastasis in breast cancer. However, limitations remained. Artificial intelligence, including deep learning and machine learning algorithms, has emerged as a possible technique, which can make a more accuracy prediction through machine-based collection, learning and processing of previous information, especially in radiology and pathology-based diagnosis. With the intensification of the concept of precision medicine and the development of non-invasive technology, the investigators intend to use the artificial intelligence technology to develop a serum and tissue-based predictive model for sentinel lymph node metastasis diagnosis combined with imaging and pathological information, providing specific, efficient and non-invasive biological indicators for the monitoring and early intervention of lymph node metastasis in patient with breast cancer. Therefore, the investigators retrospectively include serum samples from early breast cancer patients undergoing sentinel lymph node biopsy, including a discovery cohort and a modeling cohort. Metabolites were detected and screened in the discovery cohort and then as the target metabolites for targeted detection in the modeling cohort. Combined with preoperative imaging and pathological information, a prediction model of breast cancer sentinel lymph node metastasis based on serum metabolites would be established. Subsequently, multi-center breast cancer patients will prospectively be included to verify the accuracy and stability of the model.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathological diagnosis of breast cancer
No preoperative therapy including chemotherapy or endocrine therapy
No distant metastasis
Underwent mastectomy or breast-conserving surgery with sentinel lymph node biopsy
Disqualifiers
Neoadjuvant therapy
Presence of distant metastasis at time of diagnosis
Primary malignancies other than breast cancer
Bilateral breast cancer or previous contralateral breast cancer
Trial population
Retrospective cohort: The study retrospectively collected data from 724 patients with early breast cancer. Prospective cohort: We expected the accuracy of our predictive model reached 96%, and given an estimated dropout rate of 10%. We needed to include at least 586 breast cancer in the prospective cohort. Therefore, we plan to prospectively enroll serum samples from 586 breast cancer patients to detect the abundance of metabolites and collect the radiological and pathological information from these patients for the following analysis.
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Metabolic difference detection
Serum metabolites difference between breast cancer patients with and without sentinel lymph node metastasis would be analyzed, and potential biological indicators found.
Predictive model establishment
Combined with preoperative imaging and pathological information, a predictive model of sentinel lymph node metastasis in breast cancer would be established based on the metabolic difference.
Predictive model validation
Verify the stability and accuracy of our model in larger cohorts and promote clinical translation.
Sponsors and contacts
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Shantou Central Hospital
Lead sponsor
Zhejiang Cancer Hospital
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Shenshan Medical Center of Sun Yat-sen Memorial Hospital
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator