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Study identifier: NCT06001528 Synced from ClinicalTrials.gov · August 09, 2026
● Study status: Recruiting

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

Condition: Breast Cancer · Lymph Node Metastasis  ·  Sponsor: Shantou Central Hospital

PhaseN/A
Planned participants2400
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
WhereShantou, Guangdong, China

Interested? Contact the study team ↓

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Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.See where this study is running →

About this study

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 sentin…

This description comes directly from the study's public registry record.

Talk to the study team

Xiaorong Lin, Dr.  ·  13790891600  ·  clarelynn_lin@163.com

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Full eligibility criteria (exactly as the study team wrote them)

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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (1)

Shantou Central HospitalShantou, Guangdong, ChinaRecruiting

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