Non-Invasive Diagnosis of Endometrial Cancer (NIECE)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Endometrial Cancer

Treatments: Procedure: cervical cytology during surgery.

Study type: Interventional

Funder types: Other

Identifiers

NCT05737797

APHP221027

Details and patient eligibility

About

The study aims to determine whether next generation sequencing and microsatellite analysis of cervical cytology is sensitive for the detection of endometrial carcinoma.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Chemotherapy

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Endometrial cancer patients

Experimental group

Description:

Endometrial cancer patients Cervical cytology during surgical intervention.

Treatment:

Procedure: cervical cytology during surgery.