Non-Invasive Diagnosis of Endometrial Cancer (NIECE)
February 21, 2024 updated by: Assistance Publique - Hôpitaux de Paris
The study aims to determine whether next generation sequencing and microsatellite analysis of cervical cytology is sensitive for the detection of endometrial carcinoma.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Patrick BENUSIGLIO, MD PhD
- Phone Number: + 33 1 42 17 76 59
- Email: patrick.benusiglio@aphp.fr
Study Contact Backup
- Name: Clémence EVREVIN, MD
- Phone Number: + 33 1 42 17 76 59
- Email: Clemence.evrevin@aphp.fr
Study Locations
-
-
-
Paris, France
- Recruiting
- Medical genetics department
-
Contact:
- Clémence EVREVIN, MD
- Phone Number: + 33 1 42 17 76 59
- Email: Clemence.evrevin@aphp.fr
-
Contact:
- Patrick BENISIGLIO, MD PhD
- Phone Number: + 33 1 42 17 76 59
- Email: patrick.benusiglio@aphp.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Endometrial cancer requiring hysterectomy
- Patient covered by French social Security
- Patient capable of giving written informed consent
Exclusion Criteria:
- Chemotherapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Endometrial cancer patients
Endometrial cancer patients Cervical cytology during surgical intervention.
|
Cervical cytology will be performed by the surgeon in the operating theatre before hysterectomy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Activating variants and MSI via cytology
Time Frame: 16 months
|
proportion of cases in whom genetic activating variants and microsatellite instability are detected by cytology
|
16 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Type of variants
Time Frame: 16 months
|
Variant details
|
16 months
|
|
Number of variants
Time Frame: 16 months
|
Variant details
|
16 months
|
|
Frequency of variants
Time Frame: 16 months
|
Variant details
|
16 months
|
|
Comparison with the proportion of variants seen on the pathological
Time Frame: 16 months
|
Tumoral correlation
|
16 months
|
|
Comparison with the proportion of microsatellite instability detected on the pathological specimen.
Time Frame: 16 months
|
Tumoral correlation
|
16 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2023
Primary Completion (Estimated)
October 10, 2024
Study Completion (Estimated)
October 10, 2024
Study Registration Dates
First Submitted
December 26, 2022
First Submitted That Met QC Criteria
February 10, 2023
First Posted (Actual)
February 21, 2023
Study Record Updates
Last Update Posted (Estimated)
February 22, 2024
Last Update Submitted That Met QC Criteria
February 21, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP221027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.