NIECE: Non-Invasive Diagnosis of Endometrial Cancer

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05737797
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 14.9
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Procedure: cervical cytology during surgery.	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Non-Invasive Diagnosis of Endometrial Cancer
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endometrial cancer patients Endometrial cancer patients Cervical cytology during surgical intervention.	Procedure: cervical cytology during surgery.; Cervical cytology will be performed by the surgeon in the operating theatre before hysterectomy.

Outcome Measures

Primary Outcome Measures

1. Activating variants and MSI via cytology [12 months]

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

Secondary Outcome Measures

1. Type of variants [12 months]

   Variant details

2. Number of variants [12 months]

   Variant details

3. Frequency of variants [12 months]

   Variant details

4. Comparison with the proportion of variants seen on the pathological [12 months]

   Tumoral correlation

5. Comparison with the proportion of microsatellite instability detected on the pathological specimen. [12 months]

   Tumoral correlation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Endometrial cancer requiring hysterectomy

• Patient covered by French social Security

• Patient capable of giving written informed consent

Exclusion Criteria:

• Chemotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical genetics department	Paris		France

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT05737797
• Other Study ID Numbers: APHP221027
• First Posted: Feb 21, 2023
• Last Update Posted: Feb 24, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: Endometrial cancer; Next-generation sequencing; Screening; Microsatellite instability
• Additional relevant MeSH terms: Endometrial Neoplasms

Study Results

No Results Posted as of Feb 24, 2023