Clinical trial NCT06841653: A.I and Machine Learning Based Risk Prediction Model to Improve the Clinical Management of Endometrial Cancer.
Official title: A.I and Machine Learning Based Risk Prediction Model to Improve the Clinical Management of Endometrial Cancer: a Composite Approach Integrating the MultiOMics IMmune-IConographic Pattern (MOMIMIC Score) Towards Precision Oncology and Surgery.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrium Cancer
Keywords: MultiOMics IMmune-IConographic pattern
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: University of Rome Tor Vergata
name: Casa Sollievo della Sofferenza-IRCCS, San Giovanni Rotondo
name: Universita degli Studi di Palermo
First posted: 2025-02-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from endometrial cancer.

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.

Detailed description: Identify new risk factors for endometrial cancer, using an integrated multi-omics approach linked to a specific immune pattern (called MOMIMIC score) useful for improving oncology and surgery precision. The aim is to evaluate the predictive value of the MOMIMIC score for early identification of progression from precancerous lesions to endometrial carcinoma, prognosis and relapses, to help the clinician in the decision to treatments. Through the identification during hysteroscopy of the most appropriate site for biopsies targeted endometrials, through an artificial intelligence algorithm applied to the video system hysteroscopic which, by comparing the information from the omics approach and the hysteroscopic image combined with radiogenomic information, it could help the gynecologist in the procedure and provide information on the prognosis through the omics-iconographic profile in order to calculate a preoperative predictive score. Furthermore by modulating the surgical radicality, according to the information obtained, there will be a tendency to preserve fertility in young patients with a low-risk profile (since currently the risk factors are not sufficient to discriminate for a non-treatment radical). This will help the surgeon through an artificial intelligence algorithm applied to the system robotic/laparoscopic video, will guide the operator in decision-making procedures regarding the resection margins tumor, metastasis localization, pathological lymph node detection, and imaging driven by biomolecular information.

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.

Primary outcomes:
measure: OS (overall survival)
timeFrame: 24 months
measure: DSF (disease-free survival)
timeFrame: 24 months
Secondary outcomes:
measure: Area under the curve (AUC)
timeFrame: 24 months
measure: Accuracy (ACC)
timeFrame: 24 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS National Cancer Institute "Regina Elena"
Study officials:
References: