Serum and Tissue Metabolite-based Prediction of Sentinel Lymph Node Metastasis in Breast Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorShantou Central Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

2,400 Participants
are grouped into 3 trial groups
Group A: Discovering cohort
Group B: Modeling cohort
Group C: Validation cohort

Trial outcomes

Primary outcomes

1

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.

Time frame
From January 01, 2021 to December 31, 2021
2

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.

Time frame
From January 01, 2022 to December 31, 2022
3

Predictive model validation

Verify the stability and accuracy of our model in larger cohorts and promote clinical translation.

Time frame
From January 01, 2023 to December 31, 2023

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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