Radiomics and Molecular Classification in Endometrial Cancer

NCT ID: NCT06963385

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endometrial Cancer Uterine Cancer Endometrium Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Radiomics analysis and molecular/genomic profiling

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.

Group Type EXPERIMENTAL

Radiomics

Intervention Type 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

Interventions

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Radiomics

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role lead

Responsible Party

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Valentina Chiappa

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Int140/20

Identifier Type: -

Identifier Source: org_study_id

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