Non-Invasive Diagnosis of Endometrial Cancer

Not Applicable

Recruiting

• Conditions: Endometrial Cancer
• Interventions: Procedure: cervical cytology during surgery.

• Registration Number: NCT05737797
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study First Submitted: 2022-12-26
• Study First Submitted QC: 2023-02-10
• Study First Posted: 2023-02-21
• Study Start: 2023-03-03
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22
• Primary Completion: 2024-10-10
• Study Completion: 2024-10-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Endometrial cancer requiring hysterectomy
• Patient covered by French social Security
• Patient capable of giving written informed consent

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Exclusion Criteria

• Chemotherapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endometrial cancer patients	cervical cytology during surgery.	Endometrial cancer patients Cervical cytology during surgical intervention.

Primary Outcome Measures

Name	Time	Method
Activating variants and MSI via cytology	16 months	proportion of cases in whom genetic activating variants and microsatellite instability are detected by cytology

Secondary Outcome Measures

Name	Time	Method
Comparison with the proportion of variants seen on the pathological	16 months	Tumoral correlation
Frequency of variants	16 months	Variant details
Number of variants	16 months	Variant details
Comparison with the proportion of microsatellite instability detected on the pathological specimen.	16 months	Tumoral correlation
Type of variants	16 months	Variant details

Trial Locations

Locations (1)

Medical genetics department; 🇫🇷 Paris, France