NCT04560491

Brief Summary

More than half of the cases with macrometastatic sentinel lymph node (SLN) have non-SLN metastasis and leaving these nodes in-situ may impair the survival. This study assessed the diagnostic accuracy of intraoperative SLN frozen section examination and scrape cytology as a possible solution for management of SLN positive patients. Clinical early stage endometrial cancer patients who underwent SLN algorithm and intraoperative frozen section or scrape cytology to evaluate SLN status for metastasis were analyzed retrospectively. Intraoperative examination findings were compared with final pathology results and diagnostic accuracy of frozen section and scrape cytology were evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

4.2 years

First QC Date

September 18, 2020

Last Update Submit

September 18, 2020

Conditions

Endometrial CancerSentinel Lymph Node

Outcome Measures

Primary Outcomes (1)

  • Sensitivity for the diagnosis of metastatic lymph node intraoperatively

    intraoperative test

Study Arms (2)

Frozen section

Patients underwent intraoperative sentinel node examination by frozen section

Diagnostic Test: Intraoperative examination of sentinel node

Scrape cytology

Patients underwent intraoperative sentinel node examination by scrape cytology

Diagnostic Test: Intraoperative examination of sentinel node

Interventions

Intraoperative examination of sentinel nodeDIAGNOSTIC_TEST

Intraoperative examination of sentinel node by either frozen section or scrape cytology to detect metastasis and decide for further lymphadenectomy.

Frozen sectionScrape cytology

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales older than 18 years old with early stage endometrial cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with clinical early stage endometrial cancer and underwent sentinel lymph node biopsy with intraoperative examination of sentinel node by either frozen section or scrape cytology.

You may qualify if:

  • Patients with apparently early stage endometrial cancer whose SLNs were evaluated intraoperatively were included to this study

You may not qualify if:

  • Patients with gross metastatic disease
  • Patients who had contraindications to dyes (iodine allergy or hepatic impairments)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University

Ankara, 06610, Turkey (Türkiye)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Professor

Study Record Dates

First Submitted

September 18, 2020

First Posted

September 23, 2020

Study Start

February 1, 2016

Primary Completion

April 1, 2020

Study Completion

June 30, 2020

Last Updated

September 23, 2020

Record last verified: 2020-09

Locations

TU(1)