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

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

NCT ID: NCT06250010

Condition: Endometrial Cancer

Conditions: Official terms:
Endometrial Neoplasms

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Other

Intervention:

Intervention type: Diagnostic Test
Intervention name: tissue samples (healthy and tumor taken from the same patient) and tissue samples (decidualized endometrium and trophoblast taken from it patient)
Description: 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.
Arm group label: Cohort 1: tissue samples (healthy and tumor taken from the same patient)
Arm group label: Cohort 2: tissue samples (decidualized endometrium and trophoblast taken from it patient)

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.

Criteria for eligibility:

Study pop:
Oncology patients who have undergone or will undergo to surgery. And patients with ongoing miscarriage who do will undergo surgery.

Sampling method: Non-Probability Sample
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.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: "Regina Elena" National Cancer Institute

Address:
City: Rome
Zip: 00144
Country: Italy

Status: Recruiting

Contact:
Last name: Valentina Bruno, Doctor

Phone: nd
Email: valentina.bruno@ifo.gov.it

Start date: December 13, 2022

Completion date: December 13, 2025

Lead sponsor:
Agency: Regina Elena Cancer Institute
Agency class: Other

Collaborator:
Agency: Federico II University
Agency class: Other

Source: Regina Elena Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06250010