NCT06841653 A.I and Machine Learning Based Risk Prediction Model to Improve the Clinical Management of Endometrial Cancer.
| NCT ID | NCT06841653 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Regina Elena Cancer Institute |
| Condition | Endometrium Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-06-20 |
| Primary Completion | 2026-06-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-06-20 with a primary completion date of 2026-06-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prediction of preoperative endometrial biopsy: the evolution from hyperplasia to cancer, the prognosis and the risk of recurrence. Intelligence methods artificial risk will be used to redefine the current risk classes including our profile immuno-mutational to provide a more precise characterization and closer to the real prognosis of the patient.
Eligibility Criteria
Inclusion Criteria: * Age \> 18 years; * Histological diagnosis of endometrial hyperplasia, endometrioid adenocarcinoma of the endometrium, healthy endometrium in patients undergoing total hysterectomy for benign extra-endometrial disease; * Written informed consent (to the study and data processing), for the party's patients only prospective and/or in follow-up) For the retrospective cohort: availability of samples adequately stored at the biobank of the Institute and availability of data relating to follow-up (at least 2 years) Exclusion Criteria: All exclusion criteria adopted in the surgical protocols will be applied to the study. In particular: * Comorbidities not controlled with adequate medical therapy; * Infections of the endometrial cavity (pyometra); * Synchronous cancer; * Neoadjuvant treatments; * Previous radiotherapy treatments of the pelvic region; * Hormone therapies.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06841653 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometrium Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06841653 currently recruiting?
Yes, NCT06841653 is actively recruiting participants. Contact the research team at enrico.vizza@ifo.it for enrollment information.
Where is the NCT06841653 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06841653 clinical trial?
NCT06841653 is sponsored by Regina Elena Cancer Institute. The trial plans to enroll 40 participants.
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