NCT05737797

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

March 3, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

1.6 years

First QC Date

December 26, 2022

Last Update Submit

February 21, 2024

Conditions

Endometrial Cancer

Keywords

Endometrial cancerNext-generation sequencingScreeningMicrosatellite instability

Outcome Measures

Primary Outcomes (1)

  • Activating variants and MSI via cytology

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

    16 months

Secondary Outcomes (5)

  • Type of variants

    16 months

  • Number of variants

    16 months

  • Frequency of variants

    16 months

  • Comparison with the proportion of variants seen on the pathological

    16 months

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

    16 months

Study Arms (1)

Endometrial cancer patients

EXPERIMENTAL

Endometrial cancer patients Cervical cytology during surgical intervention.

Procedure: cervical cytology during surgery.

Interventions

cervical cytology during surgery.PROCEDURE

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

Endometrial cancer patients

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- Chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical genetics department

Paris, France

RECRUITING

MeSH Terms

Conditions

Endometrial NeoplasmsMicrosatellite Instability

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenomic InstabilityPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Patrick BENUSIGLIO, MD PhD

CONTACT

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

Clémence EVREVIN, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2022

First Posted

February 21, 2023

Study Start

March 3, 2023

Primary Completion

October 10, 2024

Study Completion

October 10, 2024

Last Updated

February 22, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)