NCT07269535Not yet recruiting
A Prospective Validation Study of Radiomics in the Differential Diagnosis of Uterine Leiomyoma and Uterine Sarcoma
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 26 Nov 2025
- Start date
- 30 Sept 2026
- Primary completion date
- 1 Jan 2050
- Lead sponsor
- Tongji Hospital
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT07269535
What you commit to
- Study type: Observational
- Planned participants: 500
- From 30 Sept 2026 to the primary completion date, 1 Jan 2050
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Inclusion Criteria:
- 1.1 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.
- 1.2 Patients scheduled for surgical treatment or those eligible for long-term standardized follow-up.
- 1.3 Patients who are able to understand the study procedures and voluntarily sign the written informed consent form.
- Exclusion Criteria:
- 2.1 Patients with severe organic diseases or a previous confirmed diagnosis of other malignant uterine tumors.
- 2.2 Patients unable to complete baseline examinations, unable to comply with long-term follow-up, or unwilling to provide written informed consent.
Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.