NCT02069171

Brief Summary

The purpose of this study is to identify the incidence,feature,clinical significance for leg lymphedema after gynecologic cancer treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
333

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Shorter than P25 for all trials

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

June 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2013

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
Last Updated

February 24, 2014

Status Verified

February 1, 2014

Enrollment Period

5 months

First QC Date

May 31, 2013

Last Update Submit

February 19, 2014

Conditions

Keywords

Lower extremity edemaLower leg lymphedemaLower leg edemaLymphedemaPelvic lymph node dissectionGynecologic Cancer Lymphedema Questionnaire

Outcome Measures

Primary Outcomes (1)

  • Gynecologic Cancer Lymphedema Questionnaire

    There are no more follow up except one time telephone interview.

    The study outcome measure will be assessed by telephone interview , one time.

Study Arms (3)

early ovarian cancer group

locally advanced cervical cancer group

primary endometrial cancer group

Eligibility Criteria

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

the patient who gynecologic cancer treatment at National Cancer Center (2001\~2011)

You may qualify if:

  • the patient who gynecologic cancer treatment at National Cancer Center , Korea(2001\~2011)
  • no active cancer treatment at the moment
  • available telephone communication

You may not qualify if:

  • \<More information by cancer type\>
  • \*early ovarian cancer (FIGO stage I and II) at National Cancer Center, Korea who underwent cytoreductive and staging surgery between January 2001 and December 2010
  • locally advanced cervical cancer group patients with locally advanced cervical cancer who treatment at National Cancer Center, Korea between October 2001 and July 2007. Of 222 patients with locally advanced cervical cancer, 74 patients were underwent pretreatment laparoscopic surgical staging and 148 patients received radiotherapy . Women with locally advanced cervical cancer, no active treatment at survey, available telephone communication, and ability and willingness to provide verbal informed consent were considered to include in the current study.
  • primary endometrial cancer group patients with endometrial cancer who underwent surgery, no active treatment at survey, available telephone communication, and ability and willingness to provide verbal informed consent were considered to include in the current study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Myong Cheol Lim, MD,PhD

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty, Center for Uterine Cancer

Study Record Dates

First Submitted

May 31, 2013

First Posted

February 24, 2014

Study Start

June 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 24, 2014

Record last verified: 2014-02