Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05737797
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2022-12-26
Brief Title:
Non-Invasive Diagnosis of Endometrial Cancer
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Non-Invasive Diagnosis of Endometrial Cancer
Status:
RECRUITING
Status Verified Date:
2024-02
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:
NIECE
Brief Summary:
The study aims to determine whether next generation sequencing and microsatellite analysis of cervical cytology is sensitive for the detection of endometrial carcinoma
Detailed Description:
Definitive diagnosis of endometrial cancer relies on endometrial biopsy in addition to imaging Biopsy is however invasive and often painful and its sensitivity in only moderate Cervical cytology could be an alternative This is a proof-of-concept study The investigators will carry out next generation sequencing of cervical cytology in patients with confirmed endometrial carcinoma in order to determine whether activating variants are identified About 15 of endometrial carcinomas are microsatellite instable MSI The investigators will therefore also carry out MSI analysis using MSICare in the subset of cases with MMR-deficient cancer
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