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AI-Assisted System for Accurate Diagnosis and Prognosis of Breast Phyllodes Tumors

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Sun Yat-sen University

Status

Enrolling

Conditions

Artificial Intelligence
Diagnosis
Phyllodes Breast Tumor
Multiomics
Prognostic Cancer Model

Treatments

Diagnostic Test: imaging

Study type

Observational

Funder types

Other

Identifiers

NCT06286267
SYSKY-2023-351-02

Details and patient eligibility

About

Breast phyllodes tumor (PT) is a rare fibroepithelial tumor, accounting for 1% to 3% of all breast tumors, categorized by the WHO into benign, borderline, and malignant, based on histopathology features such as tumor border, stromal cellularity, stromal atypia, mitotic activity and stromal overgrowth. Malignant PTs account for 18%-25%, with high local recurrence (up to 65%) and distant metastasis rates (16%-25%). Benign PT could progress to malignancy after multiple recurrences. Therefore, Early, accurate diagnosis and identification of therapeutic targets are crucial for improving outcomes and survival rates.

In recent years, there has been growing interest in the application of artificial intelligence (AI) in medical diagnostics. AI can integrate clinical information, histopathological images, and multi-omics data to assist in pathological and clinical diagnosis, prognosis prediction, and molecular profiling.AI has shown promising results in various areas, including the diagnosis of different cancers such as colorectal cancer, breast cancer, and prostate cancer. However, PT differs from breast cancer in diagnosis and treatment approach. Therefore, establishing an AI-based system for the precise diagnosis and prognosis assessment of PT is crucial for personalized medicine.

The research team, led by Dr. Nie Yan, is one of the few in Guangdong Province and even nationally, specializing in PT research. Their team has been conducting research on the malignant progression, metastasis mechanisms, and molecular markers for PT. The team has identified key mechanisms, such as fibroblast-to-myofibroblast differentiation, and the role of tumor-associated macrophages in promoting this differentiation. They have also identified molecular markers, including miR-21, α-SMA, CCL18, and CCL5, which are more accurate in predicting tumor recurrence risk compared to traditional histopathological grading.

The project has collected high-quality data from nearly a thousand breast PT patients, including imaging, histopathology, and survival data, and has performed transcriptome gene sequencing on tissue samples. They aim to build a comprehensive multi-omics database for breast PT and create an AI-based model for early diagnosis and prognosis prediction. This research has the potential to improve the diagnosis and treatment of breast PT, address the disparities in breast PT care across different regions in China, and contribute to the development of new therapeutic targets.

Enrollment

4,000 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients diagnosed with a phyllodes tumor of the breast

Exclusion criteria

  • Blurred images, imaging artifacts

Trial design

4,000 participants in 1 patient group

Breast phyllodes tumor
Description:
Patients diagnosed with phyllodes tumor of breast
Treatment:
Diagnostic Test: imaging

Trial contacts and locations

4

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Central trial contact

Yan Nie, Prof.Dr.

Data sourced from clinicaltrials.gov

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