Non-Invasive Diagnosis of Endometrial Cancer

Endometrial Cancer Clinical Trial

— NIECE  

Official title:

Non-Invasive Diagnosis of Endometrial Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05737797
• Other study ID #: APHP221027
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2023
• Est. completion date: October 10, 2024

Study information

• Verified date: February 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Patrick BENUSIGLIO, MD PhD
• Phone: + 33 1 42 17 76 59
• Email: patrick.benusiglio[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 10, 2024
• Est. primary completion date: October 10, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Endometrial cancer requiring hysterectomy

• Patient covered by French social Security

• Patient capable of giving written informed consent

Exclusion Criteria:

• Chemotherapy

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Procedure:
• cervical cytology during surgery.
Cervical cytology will be performed by the surgeon in the operating theatre before hysterectomy.

Locations

Country	Name	City	State
France	Medical genetics department	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activating variants and MSI via cytology	proportion of cases in whom genetic activating variants and microsatellite instability are detected by cytology	16 months
Secondary	Type of variants	Variant details	16 months
Secondary	Number of variants	Variant details	16 months
Secondary	Frequency of variants	Variant details	16 months
Secondary	Comparison with the proportion of variants seen on the pathological	Tumoral correlation	16 months
Secondary	Comparison with the proportion of microsatellite instability detected on the pathological specimen.	Tumoral correlation	16 months