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Recruiting NCT06841653

NCT06841653 A.I and Machine Learning Based Risk Prediction Model to Improve the Clinical Management of Endometrial Cancer.

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Clinical Trial Summary
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

Trial Parameters

Condition Endometrium Cancer
Sponsor Regina Elena Cancer Institute
Study Type OBSERVATIONAL
Phase N/A
Enrollment 40
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2024-06-20
Completion 2026-06-20

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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.

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