Actively Recruiting

FEMALE
ID06286267

Development of an Artificial Intelligence-Based System for Precise Diagnosis and Prognosis of Breast Phyllodes Tumors

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-02-29

4000

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

Sponsors

S

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Lead Sponsor

S

Sun Yat-sen University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Breast phyllodes tumor (PT) is a rare type of breast tumor classified into benign, borderline, and malignant categories based on specific tissue features. Malignant PTs have a high chance of coming back locally and spreading to other parts of the body. Early and accurate diagnosis along with identifying treatment targets is important to improve patient outcomes. This research focuses on using artificial intelligence (AI) to combine clinical, imaging, and genetic data to help diagnose and predict the prognosis of breast PT. The study collects high-quality data from nearly a thousand patients with breast PT, including various medical images such as ultrasound, mammography, CT, and MRI, along with tissue gene sequencing. Researchers aim to build a detailed multi-omics database and develop an AI-based system that can support early diagnosis and predict how the tumor may progress. This system is designed to assist personalized treatment decisions and address care differences across regions. Participants diagnosed with breast PT will contribute their imaging and tissue data. Researchers will assess outcomes like diagnostic sensitivity, false-negative and false-positive rates, and accuracy over five years using statistical measures such as the receiver operating characteristic curve. The study involves no treatment interventions but focuses on observation and data analysis to improve diagnostic tools. The research is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University and started in March 2023, with an expected completion by the end of 2027.

CONDITIONS

Brief Title

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

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with a phyllodes tumor of the breast
Not Eligible

You will not qualify if you...

  • Blurred images or imaging artifacts that affect quality

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Up to 5 years

Participants undergo medical imaging procedures including ultrasound, mammography, CT, and MRI to assist in diagnosis and prognosis of breast phyllodes tumors.

Trial Site Locations

Total: 4 locations

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510050

Actively Recruiting

2

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China, 510120

Actively Recruiting

3

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510145

Actively Recruiting

4

Guangdong Maternal and Child Health Hospital

Guangzhou, Guangdong, China, 511400

Actively Recruiting

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Research Team

Y

Yan Nie, Prof.Dr.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Artificial intelligence modelling in differentiating core biopsies of fibroadenoma from phyllodes tumor.

Chee Leong Cheng, Nur Diyana Md Nasir, Gary Jian Zhe Ng...

https://pubmed.ncbi.nlm.nih.gov/34819630

Tumor-Associated Macrophages Promote Malignant Progression of Breast Phyllodes Tumors by Inducing Myofibroblast Differentiation.

Yan Nie, Jianing Chen, Di Huang...

https://pubmed.ncbi.nlm.nih.gov/28512246