NCT04958278

Brief Summary

According to ESGO-ESTRO-ESMO guidelines, pelvic Sentinel lymph node detection is suitable for lymph node staging in endometrial carcinoma of the uteri. Nonetheless, a learning curve is mandatory to ensure the surgical quality of the sampling. The aim of the study is to assess the success of sentinel lymph node detection according to SHREC-Trial surgical strategy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

July 12, 2021

Status Verified

April 1, 2021

Enrollment Period

1.3 years

First QC Date

July 1, 2021

Last Update Submit

July 1, 2021

Conditions

Endometrial Cancer

Keywords

endometrial cancer

Outcome Measures

Primary Outcomes (1)

  • Bilateral node detection rates

    target = 70% to 90%

    Day 0 (during surgery)

Secondary Outcomes (4)

  • sentinel nodes

    Day 0 (during surgery)

  • Salvage operations in case of GS failure

    Day 0 (during surgery)

  • adverse events

    Day 30

  • factors for detection failure

    Day 0 (during surgery)

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30 patients over 18 months total duration of the study 20 months

You may qualify if:

  • Letter of non objection Endometrial carcinoma Stage FIGO I-II whatever the histological subtype. ESGO-ESMO-ESTRO 2021 risk classification : low, intermediate, high intermediate, high Laparoscopic approach.

You may not qualify if:

  • Participation refusal Medical contraindication to laparoscopic approach. Stage FIGO \> II Suspected Indocyanine Green allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Pierre-François DUPRE, MD

CONTACT

+33 2 98 22 37 59pierre-françois.dupre@chu-brest.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2021

First Posted

July 12, 2021

Study Start

July 1, 2021

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

July 12, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning 18 month and ending five years following the publication
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR(1)