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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorTongji Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • No intervention (observational study)

    Other intervention

    This study is a retrospective observational study without intervention.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Patients with a pathological diagnosis of uterine fibroids1 intervention
Group B: Patients with a pathological diagnosis of uterine fibroids or uterine sarcoma1 intervention

Trial outcomes

Primary outcomes

1

AUC

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

Time frame
Histopathological diagnosis obtained from surgical specimens within 1 week after imaging examinations.
2

Sensitivity

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

Time frame
Histopathological diagnosis obtained from surgical specimens within 1 week after imaging examinations.
3

Specificity

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

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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