NCT05737797

Non-Invasive Diagnosis of Endometrial Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
PROCEDURE	cervical cytology during surgery.	Cervical cytology will be performed by the surgeon in the operating theatre before hysterectomy.

Timeline

• Start date: 2023-03-03
• Primary completion: 2024-10-10
• Completion: 2024-10-10
• First posted: 2023-02-21
• Last updated: 2024-02-22

Locations

1 site across 1 country: France