Non-Invasive Diagnosis of Endometrial Cancer

Study Overview
=================
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.

Official Title
-----------------
Non-Invasive Diagnosis of Endometrial Cancer

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Procedure: cervical cytology during surgery.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Endometrial cancer requiring hysterectomy Patient covered by French social Security Patient capable of giving written informed consent Exclusion Criteria: - Chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endometrial cancer patients<br>Endometrial cancer patients Cervical cytology during surgical intervention. | Procedure: cervical cytology during surgery.<br>* Cervical cytology will be performed by the surgeon in the operating theatre before hysterectomy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activating variants and MSI via cytology | proportion of cases in whom genetic activating variants and microsatellite instability are detected by cytology | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of variants | Variant details | 12 months | 
| Number of variants | Variant details | 12 months | 
| Frequency of variants | Variant details | 12 months | 
| Comparison with the proportion of variants seen on the pathological | Tumoral correlation | 12 months | 
| Comparison with the proportion of microsatellite instability detected on the pathological specimen. | Tumoral correlation | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometrial cancer, Next-generation sequencing, Screening, Microsatellite instability