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

Официальное название

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.

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• OS (overall survival) [Срок оценки: 24 months]
• DSF (disease-free survival) [Срок оценки: 24 months]

Вторичные конечные точки (2)

• Area under the curve (AUC) [Срок оценки: 24 months]
• Accuracy (ACC) [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Италия · 1 центр

• IRCCS National Cancer Institute "Regina Elena" — Rome

Идентификаторы

NCT: NCT06841653 · RS203/IRE/24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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