RecruitingNCT06250010

Immunotolerance in Endometrial Cancer and at the Maternal-fetal Interface: Immunological Profiling of the Tumor Microenvironment in Risk Stratification of Recurrence

Immunotolerance in Endometrial Cancer and at the Maternal-fetal Interface: Immunological

Sponsor

Regina Elena Cancer Institute

Enrollment

30 participants

Start Date

Dec 13, 2022

Study Type

OBSERVATIONAL

Conditions

Endometrial Cancer

Summary

This pilot/exploratory study will be configured as a non-retro-prospective study interventional on endometrial tissue samples taken from surgically treated patients at the Regina Elena National Cancer Institute, IRE - IFO and stored at the Biobank of same Institute (BBIRE) (cohort 1) and on samples of decidualized endometrium and trophoblast from patients with ongoing spontaneous abortion treated surgically at the UOC of Gynecology ed Obstetrics of the Federico II University Polyclinic of Naples (cohort 2)

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria11

Cohort 1: Oncology patients
Age \>18 years
Histological diagnosis of endometrial hyperplasia with and without atypia, endometrial carcinoma endometrioid histotype at any stage of the disease (FIGO I-IV), patients subjected to hysterectomy for benign extra-endometrial pathology, patients with recurrence/metastasis from endometrioid endometrial carcinoma who undergo surgery;
Adequate biological material to be able to carry out the planned analyses;
Written informed consent (only for patients in the prospective part and/or in follow up/traceable);
For the retrospective part: availability of samples adequately stored at the biobank of the Institute and availability of data relating to follow-up (at least 36 months).
Cohort 2: Patients with ongoing spontaneous abortion
Age \>18 years;
Diagnosis of ongoing spontaneous abortion which is subjected to an instrumental review procedure of the uterine cavity, under hysteroscopic guidance;
Adequate biological material to be able to carry out the analyzes previously described;
Written informed consent.

Exclusion Criteria5

Comorbidities not controlled with adequate medical therapy;
Infections of the endometrial cavity (pyometra);
Synchronous tumors;
Neoadjuvant treatments;
Previous radiation treatments on the pelvic region.

Interventions

DIAGNOSTIC_TESTtissue samples (healthy and tumor taken from the same patient) and tissue samples (decidualized endometrium and trophoblast taken from it patient)

Correlation between the immuno-score results of each patient with his prognosis, in terms disease-free survival, overall survival, relapse-free survival, disease-specific survival cancer, distant and/or local free survival, to validate their potential role independent in the progression of endometrial cancer; later, for a better characterization of the various ones risk classes, we will combine our immuno-score with the already known risk factors, included in the ESMO-ESGO-ESTRO classification and in the biomolecular classification of endometrial cancer, to investigate whether the Microenvironmental immunological factors in endometrial cancer could allow better stratification of patients in risk classes.