A Prospective Validation Study of Radiomics in the Differential Diagnosis of Uterine Leiomyoma and Uterine Sarcoma

NCT07269535 | Not Yet Recruiting DMC

• 1 other identifier: TJ-IRB202511040
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

In our previous study, based on the multi-center clinical big data collected from January 2012 to January 2025, we have completed the construction of a multimodal early warning model for the malignant transformation of uterine fibroids. The model was mainly based on T2WI and DWI sequences, and was trained and optimized by support vector machine (SVM) algorithm. In the retrospective study and internal validation, the model shows high sensitivity and specificity, which preliminarily proves that it has good application potential in identifying high-risk groups and predicting the risk of malignant transformation of uterine fibroids. However, there are still some limitations in retrospective studies and internal validation results, and its application value, universality and stability in real clinical environment have not been fully verified. Therefore, we plan to conduct a prospective validation study in consecutive patients enrolled after January 2025 to evaluate the clinical performance and generalization of the model in predicting the malignant tendency or risk of malignant transformation of uterine fibroids through practical application in the real population, and further analyze the operability in the actual diagnosis and treatment process and the potential value for patient management. This study will provide reliable evidence for early screening, follow-up management and individualized treatment of high-risk population, and has important clinical and public health significance for improving the early diagnosis rate, reducing the risk of malignant transformation and improving the prognosis of patients with uterine fibroids.

Conditions

Radiomic; Uterine Fibroid; Uterine Sarcoma; AI (Artificial Intelligence); Prospective Observational Study; MRI

Keywords

prospective observational study; Uterine Fibroid; uterine sarcoma; AI (Artificial Intelligence); Radiomic; MRI

Outcome Measures

Primary Outcomes (3)

• AUC

  AUC stands for Area Under the Curve, specifically under the ROC (Receiver Operating Characteristic) curve

  Histopathological diagnosis obtained from surgical specimens within 1 week after imaging examinations.

• Sensitivity

  Ability of the test to correctly identify those with uterine sarcoma (true positive rate)

  Histopathological diagnosis obtained from surgical specimens within 1 week after imaging examinations.

• Specificity

  Ability of the test to correctly identify those without uterine sarcoma (true negative rate）

  Histopathological diagnosis obtained from surgical specimens within 1 week after imaging examinations.

Study Arms (2)

Patients with a pathological diagnosis of uterine fibroids

Other: No intervention (observational study)

Patients with a pathological diagnosis of uterine fibroids or uterine sarcoma

Other: No intervention (observational study)

Interventions

No intervention (observational study) OTHER

This study is a retrospective observational study without intervention.

Patients with a pathological diagnosis of uterine fibroids; Patients with a pathological diagnosis of uterine fibroids or uterine sarcoma

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a pathological diagnosis of uterine leiomyoma or uterine sarcoma will be recruited.

You may qualify if:

• Patients clinically evaluated and radiologically examined (including MRI, particularly T2WI and DWI sequences) who are diagnosed with uterine leiomyoma or considered highly suspected of uterine sarcoma, in combination with preliminary pathological findings.
• Patients scheduled for surgical treatment or those eligible for long-term standardized follow-up.
• Patients who are able to understand the study procedures and voluntarily sign the written informed consent form.

You may not qualify if:

• Patients with severe organic diseases or a previous confirmed diagnosis of other malignant uterine tumors.
• Patients unable to complete baseline examinations, unable to comply with long-term follow-up, or unwilling to provide written informed consent.

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Conditions

Leiomyoma

Interventions

Observation

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

WENWEN WANG

CONTACT

15927167698; wenwenwang@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 8, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): January 1, 2050
• Study Completion (Estimated): January 1, 2050
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share