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Cross-sectional and Questionnaire Study for Leg Lymphedema

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ClinicalTrials.gov Identifier: NCT02069171
Recruitment Status : Completed
First Posted : February 24, 2014
Last Update Posted : February 24, 2014
Sponsor:
Information provided by (Responsible Party):
Myong Cheol Lim, National Cancer Center, Korea

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

Condition or disease
Gynecologic Cancer

Detailed Description:
Medical records will reviewed. And all patients who met the inclusion criteria will contacted by a telephone call by a clinical research coordinator. The telephone interview questionnaire for Lower Extremity Edema (LEE) and gynecologic cancer lymphedema questionnaire (GCLQ) will t take approximately 20-30 min to complete. The questionnaire for LEE included onset, severity, location, duration, and management. Patients will also questioned concerning deep vein thrombosis to exclude other causes of LEE. LEE is defined as subjective edema of lower extremity based on patients' complaint. LLL is defined based on a clinical diagnosis of lymphedema by a physician.

Study Type : Observational
Actual Enrollment : 333 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Cross-sectional and Questionnaire Study of Pelvic and Lower Extremity Lymphedema After Treatment of Gynecological Disease
Study Start Date : June 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Group/Cohort
early ovarian cancer group
locally advanced cervical cancer group
primary endometrial cancer group



Primary Outcome Measures :
  1. Gynecologic Cancer Lymphedema Questionnaire [ Time Frame: The study outcome measure will be assessed by telephone interview , one time. ]
    There are no more follow up except one time telephone interview.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
the patient who gynecologic cancer treatment at National Cancer Center (2001~2011)
Criteria
  • Inclusion criteria

    1. the patient who gynecologic cancer treatment at National Cancer Center , Korea(2001~2011)
    2. no active cancer treatment at the moment
    3. available telephone communication
  • exclusion criteria 1. The patient unlikely to comply with the protocol

<More information by cancer type>

  • early ovarian cancer group Inclusion criteria were early stage epithelial ovarian cancer*, no active treatment, available telephone communication with patients, and ability and willingness to provide verbal informed consent.

    *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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069171


Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Myong Cheol Lim, MD,PhD National Cancer Center, Korea

Responsible Party: Myong Cheol Lim, Faculty, Center for Uterine Cancer, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT02069171     History of Changes
Other Study ID Numbers: NCC_GO_2012_01_2
NCCNCS-12-565 ( Other Grant/Funding Number: (South Korea) National Cancer Center , IRB )
First Posted: February 24, 2014    Key Record Dates
Last Update Posted: February 24, 2014
Last Verified: February 2014

Keywords provided by Myong Cheol Lim, National Cancer Center, Korea:
Lower extremity edema
Lower leg lymphedema
Lower leg edema
Lymphedema
Pelvic lymph node dissection
Gynecologic Cancer Lymphedema Questionnaire

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases