Clinical trial NCT06250010: Immunotolerance in Endometrial Cancer and at the Maternal-fetal Interface: Immunological Profiling of the Tumor Microenvironment in Risk Stratification of Recurrence
Official title: Immunotolerance in Endometrial Cancer and at the Maternal-fetal Interface: Immunological
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Cancer
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Federico II University
First posted: 2024-02-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Oncology patients who have undergone or will undergo to surgery. And patients with ongoing miscarriage who do will undergo surgery.

Brief 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)

Detailed description: For the experiments proposed in the project the following will be used:

Court 1: tissue samples (healthy and tumor taken from the same patient) collected at the Institute's Biobank (starting from 2017) (retro-prospective); Court 2: tissue samples (decidualized endometrium and trophoblast taken from it patient) which will be collected at the Gynecology and Obstetrics Unit of the Polyclinic Federico II University of Naples (prospective) and transfer to the Regina National Cancer Institute Elena, IRE-IFO.

Clinical data

The following data will be collected for each patient:

* Age, ethnicity, parity, luxury habits, level of education, marital status, height, weight, index of body mass
* Data on previous clinical history, previous gynecological-obstetric pathologies and any treatments, current comorbidities and medical therapies

For Cohort1 patients only:

* Data relating to the neoplastic pathology: histotype, grading, FIGO stage
* Data on oncological follow-up: any intra- or post-operative complications, any therapies adjuvants, type and data of any recurrence/metastasis, type of treatment if any recurrence, date and manner of death.

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.

Primary outcomes:
measure: Description of genetic signatures shared between the maternal-fetal interface
timeFrame: 36 months
measure: Calculation of potential immuno-score
timeFrame: 36 months
measure: characterize the risk classes
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
affiliation: IRCCS "Regina Elena" National Cancer Institute
name: Valentina Bruno, Doctor
role: PRINCIPAL_INVESTIGATOR
References: