Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Fa… (NCT06279832) | Clinical Trial Compass
UnknownNot Applicable
Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer.
Italy1,000 participantsStarted 2023-11-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.