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

NCT06273878 | Recruiting

• 1 other identifier: RS1439/20
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• Validate the differential expression of LOX-1 and NALP3 receptors.

  Validate the differential expression of LOX-1 and NALP3 receptors at different steps progression of endometrial cancer; identify immune signatures shared between using transcriptomics the maternal-fetal interface and the different stages of progression of endometrial cancer; investigate their role functional in the immune escape process in endometrial carcinoma and/or in the pro-inflammatory response.

  36 months

Secondary Outcomes (2)

• Characterize phenotypic alterations.

  36 months

• Evaluate the predictive and/or prognostic value.

  36 months

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population is represented by patients with endometrial cancer who have undergone, or who have will undergo surgery

You may qualify if:

• 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.

You may not qualify if:

• Comorbidities not controlled with adequate medical therapy;
• Infections of the endometrial cavity (pyometra);
• Synchronous tumors;
• Neoadjuvant treatments;
• Previous radiation treatments on the pelvic region.

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• Università degli Studi dell'Insubria: collaborator

Study Sites (2)

National Cancer Institute - IFO -

Rome, RM, 00144, Italy

RECRUITING

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Benito Chiofalo, Doctor

CONTACT

ND; benito.chiofalo@ifo.gov.it

Valentina Bruno, Doctor

CONTACT

ND; valentina.bruno@ifo.gov.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 23, 2024
• Study Start: January 15, 2023
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

IT (2)