Cross-sectional and Questionnaire Study for Leg Lymphedema

NCT ID: NCT02069171

Last Updated: 2014-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 333 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-11-30

Brief Summary

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

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.

Conditions

Gynecologic Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

early ovarian cancer group

No interventions assigned to this group

locally advanced cervical cancer group

No interventions assigned to this group

primary endometrial cancer group

No interventions assigned to this group

Eligibility 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

*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

Exclusion Criteria

<More information by cancer type>

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Myong Cheol Lim

Faculty, Center for Uterine Cancer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Myong Cheol Lim, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Other Identifiers

NCCNCS-12-565

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NCC_GO_2012_01_2

Identifier Type: -

Identifier Source: org_study_id