NCT04227249

Brief Summary

To verify the safety of omission of lymph node dissection in ultra-low-risk endometrial cancer (KGOG criteria), we examine the survival of women with ultra-low-risk endometrial cancer who do not undergo lymph node dissection

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Apr 2020

Longer than P75 for all trials

Status
not yet 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

Study Progress92%
Apr 2020Mar 2027

First Submitted

Initial submission to the registry

January 2, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Expected
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

4.9 years

First QC Date

January 2, 2020

Last Update Submit

January 12, 2020

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

  • 3 year recurrence free survival

    3 year recurrence free survival

    3 year since surgery

Secondary Outcomes (10)

  • 5 year recurrence free survival

    5 year since surgery

  • 5 year overall survival

    5 year since surgery

  • surgery time

    surgery visit

  • change of Functional Assessment of Cancer Therapy - General (FACT G) score from baseline

    baseline - 1week - 5week - 3month - 6month

  • change of Gynecologic Cancer Lymphedema Questionnaire - Korean (GCLQ-K) score from baseline

    baseline - 5week - 6month - 12month - 18month - 24month - 36month - 48month - 60month

  • +5 more secondary outcomes

Study Arms (1)

Experimental

women who do not undergo lymph node dissection

Procedure: no lymph node dissection

Interventions

no lymph node dissectionPROCEDURE

do not undergo lymph node dissection

Experimental

Eligibility Criteria

Age19 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

endometrial cancer with ultra-low risk for lymph node metastasis

You may qualify if:

  • endometrioid type
  • anticipated surgery omitting lymph node dissection for endometrial cancer
  • pelvis MRI, CA125 - satisfying KGOG criteria
  • no distant metastasis
  • age 19 or more

You may not qualify if:

  • other cancer within 5 yr
  • previous hysterectomy
  • previous therapy for endometrial cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

kidong kim, md

CONTACT

82 31 787 7262kidong.kim.md@gmail.com

Study Design

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

Study Record Dates

First Submitted

January 2, 2020

First Posted

January 13, 2020

Study Start

April 1, 2020

Primary Completion

March 1, 2025

Study Completion (Estimated)

March 1, 2027

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share