Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250010
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-01-16
Brief Title:
Immunotolerance in Endometrial Cancer and at the Maternal-fetal Interface Immunological Profiling of the Tumor Microenvironment in Risk Stratification of Recurrence
Sponsor:
Regina Elena Cancer Institute
Organization:
Regina Elena Cancer Institute
Study Overview
Official Title:
Immunotolerance in Endometrial Cancer and at the Maternal-fetal Interface Immunological
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilotexploratory study will be configured as a non-retro-prospective study interventional on endometrial tissue samples taken from surgically treated patients at the Regina Elena National Cancer Institute IRE - IFO and stored at the Biobank of same Institute BBIRE cohort 1 and on samples of decidualized endometrium and trophoblast from patients with ongoing spontaneous abortion treated surgically at the UOC of Gynecology ed Obstetrics of the Federico II University Polyclinic of Naples cohort 2
Detailed Description:
For the experiments proposed in the project the following will be used
Court 1 tissue samples healthy and tumor taken from the same patient collected at the Institutes Biobank starting from 2017 retro-prospective Court 2 tissue samples decidualized endometrium and trophoblast taken from it patient which will be collected at the Gynecology and Obstetrics Unit of the Polyclinic Federico II University of Naples prospective and transfer to the Regina National Cancer Institute Elena IRE-IFO
Clinical data
The following data will be collected for each patient
Age ethnicity parity luxury habits level of education marital status height weight index of body mass
Data on previous clinical history previous gynecological-obstetric pathologies and any treatments current comorbidities and medical therapies
For Cohort1 patients only
Data relating to the neoplastic pathology histotype grading FIGO stage
Data on oncological follow-up any intra- or post-operative complications any therapies adjuvants type and data of any recurrencemetastasis type of treatment if any recurrence date and manner of death
Court 1 tissue samples healthy and tumor taken from the same patient collected at the Institutes Biobank starting from 2017 retro-prospective Court 2 tissue samples decidualized endometrium and trophoblast taken from it patient which will be collected at the Gynecology and Obstetrics Unit of the Polyclinic Federico II University of Naples prospective and transfer to the Regina National Cancer Institute Elena IRE-IFO
Clinical data
The following data will be collected for each patient
Age ethnicity parity luxury habits level of education marital status height weight index of body mass
Data on previous clinical history previous gynecological-obstetric pathologies and any treatments current comorbidities and medical therapies
For Cohort1 patients only
Data relating to the neoplastic pathology histotype grading FIGO stage
Data on oncological follow-up any intra- or post-operative complications any therapies adjuvants type and data of any recurrencemetastasis type of treatment if any recurrence date and manner of death
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None