Exploring immune mechanisms in endometrial cancer
From Fetal-maternal Interface Immune Tolerance to Endometrial Cancer Immune Escape: Potential Targets for Immunotherapy
This study looks at tissue samples from patients with endometrial cancer to see how the immune system changes and if these changes affect cancer growth, with the hope of finding new treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Drugs / interventions | radiation, immunotherapy |
| Locations | 2 sites (Rome, RM and 1 other locations) |
| Trial ID | NCT06273878 on ClinicalTrials.gov |
What this trial studies
This observational study analyzes endometrial tissue samples from patients who have undergone surgery for endometrial cancer or related conditions. It aims to understand the immune adaptations at the maternal-fetal interface and how these may influence tumor progression and immune escape in endometrial cancer. By identifying molecular pathways involved in the transition from early lesions to advanced cancer, the study seeks to uncover potential targets for immunotherapy that could improve patient outcomes. The research involves both retrospective analysis of stored samples and prospective collection of new data.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a histological diagnosis of endometrial hyperplasia or carcinoma, who have adequate biological samples available.
Not a fit: Patients with uncontrolled comorbidities, infections of the endometrial cavity, synchronous tumors, or those who have received neoadjuvant treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new immunotherapy targets that enhance the immune response against endometrial cancer.
How similar studies have performed: Other studies exploring immune mechanisms in cancer have shown promise, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years; * Histological diagnosis of endometrial hyperplasia with and without atypia, carcinoma of the endometrium histotype endometrioid 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 that are subjected to surgery; * Adequate biological material to be able to carry out the analyzes previously described; * Written informed consent (only for patients in the prospective part and/or in follow-up); * For the retrospective part: availability of samples adequately stored at the Institute biobank and availability of follow-up data. 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, RM and 1 other locations
- National Cancer Institute - IFO - — Rome, Rm, Italy (Recruiting)
- "Regina Elena" National Cancer Institute — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Benito Chiofalo, Doctor
- Email: benito.chiofalo@ifo.gov.it
- Phone: ND
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.