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Radiomics and Molecular Classification in Endometrial Cancer

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06963385
Acronym
ROME
Enrollment
250
Registered
2025-05-09
Start date
2021-01-15
Completion date
2026-12-31
Last updated
2025-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer, Endometrium Tumor, Uterine Cancer

Keywords

radiomics, endometrial cancer, molecular/genetic profiling, radiogenomics, ultrasound

Brief 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.

Interventions

DIAGNOSTIC_TESTRadiomics

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

Sponsors

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Assess the intraobserver and interobserver reproducibility of radiomic features on ultrasonographic images of endometrial tumors19-36 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026