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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273878
• Other study ID #: RS1439/20
• Status: Recruiting
• Start date: January 15, 2023
• Est. completion date: January 15, 2025

Study information

• Verified date: February 2024
• Source: Regina Elena Cancer Institute
• Contact: Benito Chiofalo, Doctor
• Phone: ND
• Email: benito.chiofalo[@]ifo.gov.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Locations

Country	Name	City	State
Italy	"Regina Elena" National Cancer Institute	Rome
Italy	National Cancer Institute - IFO -	Rome	RM

Sponsors (2)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute	Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Characterize phenotypic alterations.	Characterize the phenotype and functional alterations of multiple candidate biomarkers relevant selected in AIM1 (surface antigens / cytokines / molecular pathways), a level of the cells of the immune infiltrate, in the different stages of cancer progression to the endometrium.	36 months
Secondary	Evaluate the predictive and/or prognostic value.	Evaluate the predictive and/or prognostic value of the immuno-score deriving from the data of Aim 1 and Aim 2 alone or in combination with clinical and prognostic risk factors known histopathological findings, expressed in the ESMO-ESGO-ESTRO consensus conference.	36 months