NCT01527396

Brief Summary

The purpose of this study is to evaluate the efficacy of low risk criteria for lymph node metastasis, that was determined by KGOG-2014 retrospective study, in women with endometrial cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
529

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Typical duration 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

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 7, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

3 years

First QC Date

February 2, 2012

Last Update Submit

October 27, 2015

Conditions

Endometrial Cancer

Keywords

endometrial cancerlymph node metastasislymphadenectomyrisk criteria

Outcome Measures

Primary Outcomes (3)

  • Sensitivity/Specificity

    2014-12-31

  • Negative predictive value

    2014-12-31

  • Diagnostic odds ratio

    2014-12-31

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Endometrial cancer patients who undergo surgery including systemic lymph node dissection

You may qualify if:

  • Patients with a histologic diagnosis of endometrial cancer before surgical staging.
  • Patients with a preoperative magnetic resonance imaging (MRI) and serum CA-125 within 4 weeks from surgical staging.
  • Patients who underwent adequate systemic lymph node dissection during surgical staging.

You may not qualify if:

  • Patients with a histologic feature suggesting sarcoma or squamous cell carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korean Gynecologic Oncology Group

Seoul, Kangnam-gu, 135010, South Korea

Location

MeSH Terms

Conditions

Endometrial NeoplasmsLymphatic Metastasis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sokbom Kang

    National Cancer Center, Korea

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Gynecologic Oncology Research Div.

Study Record Dates

First Submitted

February 2, 2012

First Posted

February 7, 2012

Study Start

December 1, 2011

Primary Completion

December 1, 2014

Study Completion

August 1, 2015

Last Updated

October 28, 2015

Record last verified: 2015-10

Locations

KR(1)