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

Plain Language Summary

Simplified for easier understanding

This study examines how the immune system inside uterine cancer tumors compares to the immune environment at the mother-baby interface during pregnancy. Researchers hope to identify immune patterns that predict whether endometrial (uterine) cancer is likely to return after treatment. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with endometrial hyperplasia (abnormal uterine lining) or endometrial carcinoma (uterine cancer) at any stage - You are undergoing or have undergone a hysterectomy, or you have recurrent/metastatic endometrial cancer and are having surgery - You have adequate tissue samples available for analysis - Alternatively, you are pregnant and willing to donate a placenta sample after delivery **You may NOT be eligible if...** - You do not have a confirmed diagnosis of an endometrial condition - Adequate tissue samples are not available - You are unable or unwilling to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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.