Radiomics and Molecular Classification in Endometrial Cancer (ROME)

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status: Active, not recruiting

Conditions: Endometrial Cancer; Uterine Cancer; Endometrium Tumor

Treatments: Diagnostic Test: Radiomics

Study type: Interventional

Funder types: Other

Identifiers

NCT06963385

Int140/20

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

250 participants in 1 patient group

Radiomics analysis and molecular/genomic profiling

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Radiomics