Predicting risk categories and prognostic factors in endometrial cancer using imaging and molecular data.
Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer ID: ROMANTIC STUDY
This study is testing a new way to group women with endometrial cancer into different risk levels using imaging and genetic information to help doctors choose the best treatment for them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, Lazio) |
| Trial ID | NCT06279832 on ClinicalTrials.gov |
What this trial studies
This study aims to develop radiogenomics models that categorize patients with endometrial cancer into three risk groups: Favorable, Intermediate, and Unfavorable, based on the ProMisE model. By utilizing transcriptomic profiling alongside preoperative imaging data from MRI and ultrasound, the study seeks to predict key histopathological features relevant to prognosis. The goal is to assist clinicians in personalizing treatment options according to international guidelines, enhancing decision-making for surgical and adjuvant therapies.
Who should consider this trial
Good fit: Ideal candidates include patients with pathologically confirmed primary endometrial cancer at FIGO stage IA-IB who have available preoperative imaging and tissue samples.
Not a fit: Patients with metastatic cancer, uterine sarcoma, or those who do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for patients with endometrial cancer.
How similar studies have performed: Other studies utilizing radiogenomics approaches have shown promise in cancer prognosis, suggesting potential success for this novel application in endometrial cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rome, Lazio
- Fondazione Policlinico Agostino Gemelli IRCSS — Rome, Lazio, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.