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

Artificial Intelligence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06286267
• Other study ID #: SYSKY-2023-351-02
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Yan Nie, Prof.Dr.
• Phone: +86 020-81332587
• Email: nieyan7[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with a phyllodes tumor of the breast

Exclusion Criteria:

• Blurred images, imaging artifacts

Related Conditions & MeSH terms

• Artificial Intelligence
• Breast Neoplasms
• Diagnosis
• Disease
• Phyllodes Breast Tumor
• Phyllodes Tumor

Intervention

Diagnostic Test:
• imaging
Patient medical imaging materials including ultrasound, mammography, CT, MRI

Locations

Country	Name	City	State
China	Guangdong Maternal and Child Health Hospital	Guangzhou	Guangdong
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The Third Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangdong Provincial Maternal and Child Health Hospital, Peking University Shenzhen Hospital, Sun Yat-sen University, The Third Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (10)

Belkacemi Y, Bousquet G, Marsiglia H, Ray-Coquard I, Magne N, Malard Y, Lacroix M, Gutierrez C, Senkus E, Christie D, Drumea K, Lagneau E, Kadish SP, Scandolaro L, Azria D, Ozsahin M. Phyllodes tumor of the breast. Int J Radiat Oncol Biol Phys. 2008 Feb 1;70(2):492-500. doi: 10.1016/j.ijrobp.2007.06.059. Epub 2007 Oct 10. — View Citation

Bera K, Schalper KA, Rimm DL, Velcheti V, Madabhushi A. Artificial intelligence in digital pathology - new tools for diagnosis and precision oncology. Nat Rev Clin Oncol. 2019 Nov;16(11):703-715. doi: 10.1038/s41571-019-0252-y. Epub 2019 Aug 9. — View Citation

Cheng CL, Md Nasir ND, Ng GJZ, Chua KWJ, Li Y, Rodrigues J, Thike AA, Heng SY, Koh VCY, Lim JX, Hiew VJN, Shi R, Tan BY, Tay TKY, Ravi S, Ng KH, Oh KSL, Tan PH. Artificial intelligence modelling in differentiating core biopsies of fibroadenoma from phyllodes tumor. Lab Invest. 2022 Mar;102(3):245-252. doi: 10.1038/s41374-021-00689-0. Epub 2021 Nov 24. — View Citation

Chow ZL, Thike AA, Li HH, Nasir NDM, Yeong JPS, Tan PH. Counting Mitoses With Digital Pathology in Breast Phyllodes Tumors. Arch Pathol Lab Med. 2020 Nov 1;144(11):1397-1400. doi: 10.5858/arpa.2019-0435-OA. — View Citation

Gong C, Nie Y, Qu S, Liao JY, Cui X, Yao H, Zeng Y, Su F, Song E, Liu Q. miR-21 induces myofibroblast differentiation and promotes the malignant progression of breast phyllodes tumors. Cancer Res. 2014 Aug 15;74(16):4341-52. doi: 10.1158/0008-5472.CAN-14- — View Citation

Kates-Harbeck J, Svyatkovskiy A, Tang W. Predicting disruptive instabilities in controlled fusion plasmas through deep learning. Nature. 2019 Apr;568(7753):526-531. doi: 10.1038/s41586-019-1116-4. Epub 2019 Apr 17. — View Citation

Mishra SP, Tiwary SK, Mishra M, Khanna AK. Phyllodes tumor of breast: a review article. ISRN Surg. 2013;2013:361469. doi: 10.1155/2013/361469. Epub 2013 Mar 20. — View Citation

Nie Y, Chen J, Huang D, Yao Y, Chen J, Ding L, Zeng J, Su S, Chao X, Su F, Yao H, Hu H, Song E. Tumor-Associated Macrophages Promote Malignant Progression of Breast Phyllodes Tumors by Inducing Myofibroblast Differentiation. Cancer Res. 2017 Jul 1;77(13): — View Citation

van der Laak J, Litjens G, Ciompi F. Deep learning in histopathology: the path to the clinic. Nat Med. 2021 May;27(5):775-784. doi: 10.1038/s41591-021-01343-4. Epub 2021 May 14. — View Citation

Wang Y, Acs B, Robertson S, Liu B, Solorzano L, Wahlby C, Hartman J, Rantalainen M. Improved breast cancer histological grading using deep learning. Ann Oncol. 2022 Jan;33(1):89-98. doi: 10.1016/j.annonc.2021.09.007. Epub 2021 Sep 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	The probability of a positive test result, conditional on it being truly positive.	Five years
Primary	False-negative Rate	Determine the odds of testing negative in a positive population.	Five years
Primary	Specificity	The probability of a negative test result conditional on a true negative.	Five years
Primary	False-positive Rate	Determine the odds of testing positive in a negative population.	Five years
Primary	Receiver Operating Characteristic Curve	The ROC curve is a curve based on a series of different dichotomous classifications (cut-off values or decision thresholds), with the rate of true positives (sensitivity) as the vertical coordinate and the rate of false positives (1-specificity) as the horizontal coordinate.	Five years
Primary	Area under roc Curve	AUC is defined as the area under the ROC curve enclosed with the axes, and the closer the AUC is to 1.0, the more authentic the assay is.	Five years