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Trial Title:
Non-Invasive Diagnosis of Endometrial Cancer
NCT ID:
NCT05737797
Condition:
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Conditions: Keywords:
Endometrial cancer
Next-generation sequencing
Screening
Microsatellite instability
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
cervical cytology during surgery.
Description:
Cervical cytology will be performed by the surgeon in the operating theatre before
hysterectomy.
Arm group label:
Endometrial cancer patients
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Endometrial cancer requiring hysterectomy
- Patient covered by French social Security
- Patient capable of giving written informed consent
Exclusion Criteria:
- Chemotherapy
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Medical genetics department
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Patrick BENISIGLIO, MD PhD
Phone:
+ 33 1 42 17 76 59
Email:
patrick.benusiglio@aphp.fr
Contact backup:
Last name:
Clémence EVREVIN, MD
Phone:
+ 33 1 42 17 76 59
Email:
Clemence.evrevin@aphp.fr
Start date:
March 3, 2023
Completion date:
October 10, 2024
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05737797
