Non-Invasive Diagnosis of Endometrial Cancer

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05737797

Acronym

NIECE

Enrollment

100

Registered

2023-02-21

Start date

2023-03-03

Completion date

2024-10-10

Last updated

2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

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

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.

Interventions

PROCEDUREcervical cytology during surgery.

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

\- Chemotherapy

Design outcomes

Primary

Measure	Time frame	Description
Activating variants and MSI via cytology	16 months	proportion of cases in whom genetic activating variants and microsatellite instability are detected by cytology

Secondary

Measure	Time frame	Description
Comparison with the proportion of variants seen on the pathological	16 months	Tumoral correlation
Comparison with the proportion of microsatellite instability detected on the pathological specimen.	16 months	Tumoral correlation
Type of variants	16 months	Variant details
Number of variants	16 months	Variant details
Frequency of variants	16 months	Variant details

Countries

France

Contacts

Primary ContactPatrick BENUSIGLIO, MD PhD

patrick.benusiglio@aphp.fr+ 33 1 42 17 76 59

Backup ContactClémence EVREVIN, MD

Clemence.evrevin@aphp.fr+ 33 1 42 17 76 59

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026