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Non-Invasive Diagnosis of Endometrial Cancer (NIECE)

Primary Purpose

Endometrial Cancer

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

cervical cytology during surgery.

About this trial

This is an interventional diagnostic trial for Endometrial Cancer focused on measuring Endometrial cancer, Next-generation sequencing, Screening, Microsatellite instability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Medical genetics departmentRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endometrial cancer patients

Arm Description

Endometrial cancer patients Cervical cytology during surgical intervention.

Outcomes

Primary Outcome Measures

Activating variants and MSI via cytology

proportion of cases in whom genetic activating variants and microsatellite instability are detected by cytology

Secondary Outcome Measures

Type of variants

Variant details

Number of variants

Variant details

Frequency of variants

Variant details

Comparison with the proportion of variants seen on the pathological

Tumoral correlation

Comparison with the proportion of microsatellite instability detected on the pathological specimen.

Tumoral correlation

Full Information

NCT ID

NCT05737797

First Posted

December 26, 2022

Last Updated

May 5, 2023

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT05737797

Brief Title

Non-Invasive Diagnosis of Endometrial Cancer

Acronym

NIECE

Official Title

Non-Invasive Diagnosis of Endometrial Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 3, 2023 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrial Cancer

Keywords

Endometrial cancer, Next-generation sequencing, Screening, Microsatellite instability

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Endometrial cancer patients

Arm Type

Experimental

Arm Description

Endometrial cancer patients Cervical cytology during surgical intervention.

Intervention Type

Procedure

Intervention Name(s)

cervical cytology during surgery.

Intervention Description

Cervical cytology will be performed by the surgeon in the operating theatre before hysterectomy.

Primary Outcome Measure Information:

Title

Activating variants and MSI via cytology

Description

proportion of cases in whom genetic activating variants and microsatellite instability are detected by cytology

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Type of variants

Description

Variant details

Time Frame

12 months

Title

Number of variants

Description

Variant details

Time Frame

12 months

Title

Frequency of variants

Description

Variant details

Time Frame

12 months

Title

Comparison with the proportion of variants seen on the pathological

Description

Tumoral correlation

Time Frame

12 months

Title

Comparison with the proportion of microsatellite instability detected on the pathological specimen.

Description

Tumoral correlation

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patrick BENUSIGLIO, MD PhD

Phone

+ 33 1 42 17 76 59

patrick.benusiglio@aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Clémence EVREVIN, MD

Phone

+ 33 1 42 17 76 59

Clemence.evrevin@aphp.fr

Facility Information:

Facility Name

Medical genetics department

City

Paris

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrick BENISIGLIO, MD PhD

Phone

+ 33 1 42 17 76 59

patrick.benusiglio@aphp.fr

First Name & Middle Initial & Last Name & Degree

Clémence EVREVIN, MD

Phone

+ 33 1 42 17 76 59

Clemence.evrevin@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Non-Invasive Diagnosis of Endometrial Cancer

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