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

NCT ID: NCT06250010

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-13
• Study Completion Date: 2025-12-13

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.

Conditions

Endometrial Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Cohort 1: tissue samples (healthy and tumor taken from the same patient)

Tissue samples (healthy and tumor taken from the same patient) collected at the Institute's Biobank (starting from 2017) (retro-prospective). The data relating to the neoplastic pathology will also be indicated: histotype, grading, FIGO stage. And data on oncological follow-up: any intra or post-operative complications, any adjuvant therapies, type and date of any recurrence/metastasis, type of treatment, any recurrence, date and manner of death

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

Intervention Type: DIAGNOSTIC_TEST

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.

Cohort 2: tissue samples (decidualized endometrium and trophoblast taken from it patient)

The tissue samples (decidualized endometrium and trophoblast taken from it patient) which will be collected from the Gynecology and Obstetrics Unit of the Polyclinic Federico II University of Naples (prospective) and transferred to the Regina National Cancer Institute Elena, IRE-IFO

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

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

tissue 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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: collaborator

Regina Elena Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valentina Bruno, Doctor

Role: PRINCIPAL_INVESTIGATOR

IRCCS "Regina Elena" National Cancer Institute

Locations

"Regina Elena" National Cancer Institute

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Valentina Bruno, Doctor

Role: CONTACT

valentina.bruno@ifo.gov.it

nd

Facility Contacts

Valentina Bruno, Doctor

Role: primary

valentina.bruno@ifo.gov.it

nd

Other Identifiers

RS1807/22

Identifier Type: -

Identifier Source: org_study_id