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Trial Title:
From Fetal-maternal Interface Immune Tolerance to Endometrial Cancer Immune Escape: Potential Targets for Immunotherapy
NCT ID:
NCT06273878
Condition:
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Summary:
Non-interventional retro-prospective study on Endometrial tissue samples taken from
surgically treated patients.
Detailed 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.
Criteria for eligibility:
Study pop:
The population is represented by patients with endometrial cancer who have undergone, or
who have will undergo surgery
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Institute - IFO -
Address:
City:
Rome
Zip:
00144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Benito Chiofalo, Doctor
Phone:
ND
Email:
benito.chiofalo@ifo.gov.it
Contact backup:
Last name:
Valentina Bruno, Doctor
Phone:
ND
Email:
valentina.bruno@ifo.gov.it
Facility:
Name:
"Regina Elena" National Cancer Institute
Address:
City:
Rome
Zip:
00144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Benito Chiofalo, Doctor
Phone:
ND
Email:
benito.chiofalo@ifo.it
Contact backup:
Last name:
Valentina Bruno, Doctor
Phone:
ND
Email:
valentina.bruno@ifo.gov.it
Start date:
January 15, 2023
Completion date:
January 15, 2025
Lead sponsor:
Agency:
Regina Elena Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Università degli Studi dell'Insubria
Agency class:
Other
Source:
Regina Elena Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06273878
