3 Year Recurrence Free Survival in Ultra-low-risk Endometrial Cancer (TREE PRO)

January 12, 2020 updated by: Seoul National University Hospital

Three-year Recurrence Free Survival in Patients With Ultra-low-risk Endometrial Cancer Who do Not Undergo Lymph Node dissEction

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

endometrial cancer with ultra-low risk for lymph node metastasis

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental
women who do not undergo lymph node dissection
Procedure: no lymph node dissection
do not undergo lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3 year recurrence free survival
Time Frame: 3 year since surgery
3 year recurrence free survival
3 year since surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5 year recurrence free survival
Time Frame: 5 year since surgery
5 year recurrence free survival
5 year since surgery
5 year overall survival
Time Frame: 5 year since surgery
5 year overall survival
5 year since surgery
surgery time
Time Frame: surgery visit
from surgery start to end
surgery visit
change of Functional Assessment of Cancer Therapy - General (FACT G) score from baseline
Time Frame: baseline - 1week - 5week - 3month - 6month
functional assessment of cancer therapy - general
baseline - 1week - 5week - 3month - 6month
change of Gynecologic Cancer Lymphedema Questionnaire - Korean (GCLQ-K) score from baseline
Time Frame: baseline - 5week - 6month - 12month - 18month - 24month - 36month - 48month - 60month
gynecologic cancer lymphedema questionnaire - Korean
baseline - 5week - 6month - 12month - 18month - 24month - 36month - 48month - 60month
change of Female Sexual Function Index (FSFI) score from baseline
Time Frame: baseline - 6month - 12month - 24month - 36month - 48month - 60month
female sexual function index
baseline - 6month - 12month - 24month - 36month - 48month - 60month
length of stay
Time Frame: surgery visit
from admission to discharge
surgery visit
transfusion
Time Frame: surgery visit
amount of transfusion
surgery visit
hemoglobin decline
Time Frame: surgery visit
change of hemoglobin level from baseline to postoperative lowest level
surgery visit
surgery complication
Time Frame: surgery visit
any surgery complications observed
surgery visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2027

Study Registration Dates

First Submitted

January 2, 2020

First Submitted That Met QC Criteria

January 9, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 12, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KGOG 3021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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