NCT06963385

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jan 2021Dec 2026

First Submitted

Initial submission to the registry

December 1, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
4.3 years until next milestone

First Posted

Study publicly available on registry

May 9, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 9, 2025

Status Verified

May 1, 2025

Enrollment Period

6 years

First QC Date

December 1, 2020

Last Update Submit

May 6, 2025

Conditions

Endometrial CancerUterine CancerEndometrium Tumor

Keywords

radiomicsendometrial cancermolecular/genetic profilingradiogenomicsultrasound

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Assess the intraobserver and interobserver reproducibility of radiomic features on ultrasonographic images of endometrial tumors

    19-36 months

Study Arms (1)

Radiomics analysis and molecular/genomic profiling

EXPERIMENTAL

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.

Diagnostic Test: Radiomics

Interventions

RadiomicsDIAGNOSTIC_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

Radiomics analysis and molecular/genomic profiling

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients affected by endometrial cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, 20133, Italy

Location

MeSH Terms

Conditions

Endometrial NeoplasmsUterine Neoplasms

Interventions

Radiomics

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 1, 2020

First Posted

May 9, 2025

Study Start

January 15, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 9, 2025

Record last verified: 2025-05

Locations

IT(1)