Cross-sectional and Questionnaire Study for Leg Lymphedema

Gynecologic Cancer Clinical Trial

Official title:

The Cross-sectional and Questionnaire Study of Pelvic and Lower Extremity Lymphedema After Treatment of Gynecological Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02069171
• Other study ID #: NCC_GO_2012_01_2
• Secondary ID: NCCNCS-12-565
• Status: Completed
• Phase: N/A
• First received: May 31, 2013
• Last updated: February 19, 2014
• Start date: June 2012
• Est. completion date: November 2012

Study information

• Verified date: February 2014
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Gynecologic Cancer
• Lymphedema

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No