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From Fetal-maternal Interface Immune Tolerance to Endometrial Cancer Immune Escape: Potential Targets for Immunotherapy

R

Regina Elena Cancer Institute

Status

Enrolling

Conditions

Endometrial Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT06273878
RS1439/20

Details and patient eligibility

About

Non-interventional retro-prospective study on Endometrial tissue samples taken from surgically treated patients.

Full description

The picture of precisely coordinated immune adaptations over time at the maternal-fetal interface level and altered in pregnancy complications, could reveal a specific "immune clock" in tumors. The study aims to decipher mechanisms of immunodeficiency by helping to predict recurrence in patients with endometrial cancer and identify molecular pathways that are turned on or off in progression from lesions early to advanced neoplasia. This will allow the discovery of potential immunotherapy targets to interfere with the immune escape activation process or to reactivate/re-educate the immune response.

Enrollment

80 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

2

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Central trial contact

Benito Chiofalo, Doctor; Valentina Bruno, Doctor

Data sourced from clinicaltrials.gov

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