Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer.

Not Applicable

Recruiting

• Conditions: Endometrial Cancer
• Interventions: Other: trascriptomic profiling

• Registration Number: NCT06279832
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

The aim is to develop radiogenomics models to stratify patients into three main risk categories (Favorable, Intermediate, and Unfavorable) according to the ProMisE model (9) and use these models to predict the most prognostically relevant EC histopathological features (i.e. FIGO stage, degree of tumor differentiation, histotype, LVSI status, myometrial and cervical invasion, lymph node metastases).

These models would support clinicians in personalizing surgical and adjuvant treatment choice among the options considered by the international guidelines.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2023-12-15
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

• Pathologically confirmed diagnosis of primary endometrial cancer (endometrioid, clear cell, serous, mixed, any grade)
• FIGO stage IA-IB
• Formalin-fixed, paraffin-embedded (FFPE) tissue at the diagnosis available - Availability of preoperative MRI scans in dicom (.dcm) format
• Availability of preoperative US images in dicom (.dcm) format
• Availability of preoperative CT-scan images in dicom (.dcm) format (optional)
• Available clinical information (e.g. baseline information, surgery, adjuvant therapy, median follow up period 24 months)

Exclusion Criteria

• Metastatic cancer to the uterus (not primary EC)
• Uterine sarcoma
• Conservative surgery
• FIGO stage > II
• Formalin-fixed, paraffin-embedded (FFPE) tissue at the diagnosis not available
• Patients without available MRI, US or CT-scan images on digital media
• Clinical information not available or incomplete
• Any other malignancy in the previous 5 years or synchronous
• Patients aged under 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcriptomic analyses	trascriptomic profiling	-

Primary Outcome Measures

Name	Time	Method
Predictive value of the model	up to one year	Receiver operating characteristic (ROC) curve and 95% confidence interval (CI) will be performed to determine cut-off values for the studied quantitative variables.

Secondary Outcome Measures

Name	Time	Method
Validity of the model	up to one year	To test the validity of different clinical and ultrasound variables Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) will be determined

Trial Locations

Locations (1)

Fondazione Policlinico Agostino Gemelli IRCSS; 🇮🇹 Rome, Lazio, Italy