Radiomics and Molecular Classification in Endometrial Cancer

NCT06963385 — Not applicable, Active not recruiting, 250 participants, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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Correlation Between RadiOmics and Molecular Classification in Endometrial Cancer (the ROME Study): a Step Forward to a Simplified Precision Medicine

Registry	NCT06963385, acronym ROME
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	250 (Estimated)
Sponsor	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (Other)
Conditions	Endometrial Cancer, Uterine Cancer, Endometrium Tumor
Interventions	Radiomics (Diagnostic test)
Dates	start 2021-01-15, primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2025-05-09, last updated 2025-05-09
Locations	1 site in Italy

-Summary

Molecular/genomic profiling is the most accurate method to assess the prognosis of endometrial cancer patients. Interestingly, the adoption of radiomics showed important results, across various oncologic specialties. Radiomic allows extracting mineable high-dimensional data from clinical images, thus providing a number of noteworthy information of the tumor tissues. We aim to correlate radiomic features obtained from ultrasound images with the molecular/genomic profiling to identify new hallmarks for stratification of endometrial cancer patients into different classes of risk The central hypothesis is that combining radiomic features might allow identifying various classes of risk for endometrial cancer. The rationale for the proposed research is that once validated, radiomics applied to ultrasonographic images would be an effective, innovative, and cheap method for tailor operative and postoperative treatment modality in endometrial cancer.

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+Arms and interventions

Arm	Type	Interventions	Description
Radiomics analysis and molecular/genomic profiling	Experimental	Diagnostic Test: Radiomics	This prospective single-arm observational study. Patients with newly diagnosed endometrial cancer have an ultrasonographic evaluation and radiomic analysis of the ultrasonographic images. Then patients have surgery followed by molecular/genomic evaluation. We correlate radiomic features with molecular/genomic profiling.

Radiomics (Diagnostic test): To correlate radiomic features obtained from ultrasound images with the molecular/genomic profiling to identify new hallmarks for stratification of endometrial cancer patients into different classes of risk

+Outcome measures

Primary outcomes

To detail the mechanism by which radiomic features predict the classification of endometrial cancer into various classes of risk. [1-18 months]
Determinate the scaled impact of radiomic features assessed on ultrasonographic images of endometrial tumors. [1-36 months]

Secondary outcomes

Assess the intraobserver and interobserver reproducibility of radiomic features on ultrasonographic images of endometrial tumors [19-36 months]

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

(i) preoperative endometrial cancer (any histology); (ii) preoperative ultrasonographic examination; (iii) surgical treatment; (iv) age >= 18 years; (v) signed informed consent for research purposes.

Exclusion Criteria:

(i) consent withdraw; (ii) lack of available (tumor) tissue for molecular/genomic profiling.

+Locations (1)

Facility	City	Country	Status
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano	Milan	Italy