Immunological profiling of endometrial cancer and pregnancy-related tissue samples

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

This study looks at tissue samples from women with endometrial cancer and those who have had a miscarriage to see how their immune systems might affect cancer recurrence and improve patient care.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Regina Elena Cancer Institute (other)
• Drugs / interventions: radiation
• Locations: 1 site (Rome)
• Trial ID: NCT06250010 on ClinicalTrials.gov

What this trial studies

This observational study aims to analyze endometrial tissue samples from patients with endometrial cancer and those experiencing spontaneous abortion. It will utilize both retrospective and prospective approaches, collecting data from the Regina Elena National Cancer Institute and the Federico II University Polyclinic of Naples. The study will gather clinical data, including patient demographics and oncological history, to better understand the tumor microenvironment and its implications for recurrence risk. The goal is to enhance risk stratification and improve patient outcomes through detailed immunological profiling.

Who should consider this trial

Good fit: Ideal candidates include patients over 18 years old with a histological diagnosis of endometrial cancer or those undergoing procedures for spontaneous abortion.

Not a fit: Patients with benign gynecological conditions or those under 18 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved risk stratification for recurrence in endometrial cancer patients.

How similar studies have performed: While similar studies have explored immunological profiling in cancer, this specific approach combining endometrial cancer and pregnancy-related tissue is relatively novel.

Eligibility criteria

Inclusion Criteria:

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 Criteria:

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

Where this trial is running

Rome

• "Regina Elena" National Cancer Institute — Rome, Italy (RECRUITING)

Study contacts

• Principal investigator: Valentina Bruno, Doctor — IRCCS "Regina Elena" National Cancer Institute
• Study coordinator: Valentina Bruno, Doctor

Conditions: Endometrial Cancer