Clinical trial · Interventional
Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer.
Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer ID: ROMANTIC STUDY
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| trascriptomic profiling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transcriptomic analyses
- interventionNames
- Other: trascriptomic profiling
Primary outcomes (1)
- measure
- Predictive value of the model
- timeFrame
- up to one year
- description
- Receiver operating characteristic (ROC) curve and 95% confidence interval (CI) will be performed to determine cut-off values for the studied quantitative variables.
Secondary outcomes (1)
- measure
- Validity of the model
- timeFrame
- up to one year
- description
- To test the validity of different clinical and ultrasound variables Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) will be determined
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available