Actively Recruiting

Age: 18Years +
FEMALE
NCT06250010

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

Led by Regina Elena Cancer Institute · Updated on 2024-05-31

30

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

R

Regina Elena Cancer Institute

Lead Sponsor

F

Federico II University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients older than 18 years
  • Histological diagnosis of endometrial hyperplasia with or without atypia, endometrial carcinoma endometrioid histotype at any stage (FIGO I-IV), or patients undergoing hysterectomy for benign extra-endometrial disease
  • Patients with recurrence or metastasis from endometrioid endometrial carcinoma undergoing surgery
  • Adequate biological material available for planned analyses
  • Written informed consent for prospective patients or those in follow-up
  • Availability of stored samples and follow-up data for retrospective patients (at least 36 months)
  • Diagnosis of ongoing spontaneous abortion undergoing uterine cavity review under hysteroscopic guidance
  • Adequate biological material for analyses
  • Written informed consent
Not Eligible

You will not qualify if you...

  • Uncontrolled comorbidities
  • Infections in the endometrial cavity such as pyometra
  • Presence of synchronous tumors
  • Receipt of neoadjuvant treatments
  • Previous radiation treatments to the pelvic area

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

"Regina Elena" National Cancer Institute

Rome, Italy, 00144

Actively Recruiting

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Research Team

V

Valentina Bruno, Doctor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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