Predicting lymph node metastasis in breast cancer using serum and tissue metabolites
Serum and Tissue Metabolite-based Prediction of Sentinel Lymph Node Metastasis in Breast Cancer
This study is testing if analyzing blood and tissue samples can help doctors better predict whether breast cancer has spread to lymph nodes, which could reduce the need for unnecessary surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2400 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Shantou Central Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shantou, Guangdong) |
| Trial ID | NCT06001528 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the accuracy of predicting sentinel lymph node metastasis in breast cancer patients by utilizing serum and tissue metabolites. The approach leverages artificial intelligence techniques, including deep learning and machine learning algorithms, to analyze preoperative data and enhance diagnostic precision. By focusing on patients who have undergone sentinel lymph node biopsy, the study seeks to reduce unnecessary surgeries for those with negative pathological results. The research emphasizes the importance of integrating metabolic reprogramming insights into the current diagnostic framework for breast cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are breast cancer patients who have undergone sentinel lymph node biopsy and have not received preoperative therapy.
Not a fit: Patients with distant metastasis, those who have undergone neoadjuvant therapy, or individuals with other primary malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate predictions of lymph node metastasis, potentially reducing unnecessary surgical interventions for breast cancer patients.
How similar studies have performed: Other studies utilizing artificial intelligence for diagnostic purposes in oncology have shown promising results, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Agreed to provide preoperative peripheral blood samples * Had access to imaging, pathological and follow-up data for preoperative and postoperative evaluation of the disease Exclusion Criteria: * Neoadjuvant therapy * Presence of distant metastasis at time of diagnosis * Primary malignancies other than breast cancer * Bilateral breast cancer or previous contralateral breast cancer * Undergo modified radical surgery for breast cancer without sentinel lymph node biopsy * Incomplete pathological data and follow-up data * Pregnancy and other conditions determined by the investigator to be ineligible for inclusion in the study
Where this trial is running
Shantou, Guangdong
- Shantou Central Hospital — Shantou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Hai Hu, Pro. — Zhejiang Cancer Hospital
- Study coordinator: Xiaorong Lin, Dr.
- Email: clarelynn_lin@163.com
- Phone: 13790891600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.