- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00956670
Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer (LEG)
The LymphEdema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact in Newly Diagnosed Patients
Study Overview
Status
Conditions
- Lymphedema
- Stage II Uterine Corpus Cancer
- Stage IVB Vulvar Cancer
- Stage IA Uterine Corpus Cancer
- Stage IB Uterine Corpus Cancer
- Stage IA Cervical Cancer
- Stage IB Cervical Cancer
- Stage II Vulvar Cancer
- Stage IIA Cervical Cancer
- Stage IA Vulvar Cancer
- Stage IB Vulvar Cancer
- Stage IIIA Vulvar Cancer
- Stage IIIB Vulvar Cancer
- Stage IIIC Vulvar Cancer
Detailed Description
PRIMARY OBJECTIVES:
I. To prospectively estimate the incidence of lower extremity lymphedema in patients undergoing radical surgery with a concurrent lymphadenectomy with a concurrent lymphadenectomy for a gynecologic malignancy.
II. To identify risk factors for the development of lower extremity lymphedema following radical surgery among patients with any one of the three types of gynecologic malignancy studied and to develop a corresponding predictive model.
SECONDARY OBJECTIVES:
I. To identify the effect that lower extremity lymphedema has on quality of life (QOL) (as measured with Functional Assessment of Cancer Therapy - General [FACT-G] + disease specific subscale), psychological adjustment (as measured with Impact of Events Scale [IES] and Functional Assessment of Chronic Illness Therapy [FACIT] body image items) and physical disability (of lower extremity as measured with Lower Extremity Functional Scale [LEFS]) and physical function(as measured by FACT-Functional Wellbeing [FW] subscale, FACIT disease specific items & patient-reported outcomes measurement information system [PROMIS] items) and to investigate potential protective mechanisms (FACT-Social Wellbeing [SW] subscale and patient characteristics).
II. To explore if patient self-reported symptoms (as measured with the lymphedema [LE] Symptom Measure [Cancer Lymphedema Questionnaire (GCLQ)]) are associated with the development of lymphedema in patients undergoing radical surgery for gynecologic malignancy.
TERTIARY OBJECTIVES:
I. To explore the effect of moderate or severe lymphedema (primary endpoint) on QOL outcomes, as measured by the FACT-General (G) questionnaire.
OUTLINE:
Patients with vulvar cancer undergo a radical vulvectomy or hemi-vulvectomy followed immediately by an ipsilateral or bilateral inguinal-femoral lymphadenectomy. (Closed to accrual as of June 9, 2014)
Patients with cervical cancer undergo a radical hysterectomy or trachelectomy and bilateral pelvic lymphadenectomy +/- para-aortic nodal sampling via vaginal, laparoscopic, or open route.
Patients with endometrial cancer undergo a laparoscopic-assisted vaginal hysterectomy, a total laparoscopic hysterectomy, or total abdominal hysterectomy with pelvic lymphadenectomy +/- para-aortic node sampling.
Patients undergo limb measurements at baseline, weeks 4-6, and at 3, 6, 9, 12, 18, and 24 months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham Cancer Center
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Arizona
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Phoenix, Arizona, United States, 85054
- Mayo Clinic Hospital
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Phoenix, Arizona, United States, 85012
- Gynecologic Oncology Group of Arizona
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Phoenix, Arizona, United States, 85013
- Saint Joseph's Hospital and Medical Center
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Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
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Tucson, Arizona, United States, 85719
- University of Arizona Cancer Center-North Campus
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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California
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Auburn, California, United States, 95602
- Sutter Auburn Faith Hospital
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Auburn, California, United States, 95603
- Sutter Cancer Centers Radiation Oncology Services-Auburn
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Berkeley, California, United States, 94704
- Alta Bates Summit Medical Center-Herrick Campus
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Burlingame, California, United States, 94010
- Mills - Peninsula Hospitals
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Cameron Park, California, United States, 95682
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
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Davis, California, United States, 95616
- Sutter Davis Hospital
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Duarte, California, United States, 91010
- City of Hope Comprehensive Cancer Center
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Los Angeles, California, United States, 90095
- UCLA / Jonsson Comprehensive Cancer Center
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Los Angeles, California, United States, 90027
- Kaiser Permanente Los Angeles Medical Center
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Modesto, California, United States, 95355
- Memorial Medical Center
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Mountain View, California, United States, 94040
- Palo Alto Medical Foundation-Camino Division
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Mountain View, California, United States, 94040
- Palo Alto Medical Foundation-Gynecologic Oncology
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Novato, California, United States, 94945
- Sutter Cancer Research Consortium
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Palo Alto, California, United States, 94301
- Palo Alto Medical Foundation Health Care
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Roseville, California, United States, 95661
- Sutter Cancer Centers Radiation Oncology Services-Roseville
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Roseville, California, United States, 95661
- Sutter Roseville Medical Center
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Sacramento, California, United States, 95816
- Sutter General Hospital
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San Francisco, California, United States, 94115
- California Pacific Medical Center-Pacific Campus
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Santa Cruz, California, United States, 95065
- Palo Alto Medical Foundation-Santa Cruz
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Santa Rosa, California, United States, 95403
- Sutter Pacific Medical Foundation
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Sunnyvale, California, United States, 94086
- Palo Alto Medical Foundation-Sunnyvale
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Sylmar, California, United States, 91342
- Olive View-University of California Los Angeles Medical Center
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Vacaville, California, United States, 95687
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
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Vallejo, California, United States, 94589
- Sutter Solano Medical Center/Cancer Center
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Cancer Center - Anschutz Cancer Pavilion
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Connecticut
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Hartford, Connecticut, United States, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
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Hartford, Connecticut, United States, 06102
- Hartford Hospital
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New Britain, Connecticut, United States, 06050
- The Hospital of Central Connecticut
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Delaware
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Lewes, Delaware, United States, 19958
- Beebe Medical Center
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Newark, Delaware, United States, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, United States, 19713
- Delaware Clinical and Laboratory Physicians PA
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Newark, Delaware, United States, 19713
- Medical Oncology Hematology Consultants PA
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Newark, Delaware, United States, 19718
- Christiana Care Health System-Christiana Hospital
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Newark, Delaware, United States, 19713
- Christiana Gynecologic Oncology LLC
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Newark, Delaware, United States, 19713
- Regional Hematology and Oncology PA
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Rehoboth Beach, Delaware, United States, 19971
- Beebe Health Campus
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Wilmington, Delaware, United States, 19801
- Christiana Care Health System-Wilmington Hospital
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Georgia
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Atlanta, Georgia, United States, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, United States, 30322
- Emory University/Winship Cancer Institute
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Augusta, Georgia, United States, 30912
- Augusta University Medical Center
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Columbus, Georgia, United States, 31904
- John B Amos Cancer Center
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Savannah, Georgia, United States, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Savannah, Georgia, United States, 31404
- Memorial University Medical Center
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Idaho
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Boise, Idaho, United States, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Post Falls, Idaho, United States, 83854
- Kootenai Cancer Center
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Illinois
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Danville, Illinois, United States, 61832
- Carle on Vermilion
-
Effingham, Illinois, United States, 62401
- Carle Physician Group-Effingham
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Mattoon, Illinois, United States, 61938
- Carle Physician Group-Mattoon/Charleston
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Springfield, Illinois, United States, 62781
- Memorial Medical Center
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Urbana, Illinois, United States, 61801
- Carle Cancer Center
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Urbana, Illinois, United States, 61801
- The Carle Foundation Hospital
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, United States, 46260
- Saint Vincent Hospital and Health Care Center
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Iowa
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Clive, Iowa, United States, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, United States, 50325
- Medical Oncology and Hematology Associates-West Des Moines
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Des Moines, Iowa, United States, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, United States, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, United States, 50309
- Medical Oncology and Hematology Associates-Des Moines
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Des Moines, Iowa, United States, 50316
- Iowa Lutheran Hospital
-
Des Moines, Iowa, United States, 50309
- Iowa-Wide Oncology Research Coalition NCORP
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Des Moines, Iowa, United States, 50314
- Medical Oncology and Hematology Associates-Laurel
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Iowa City, Iowa, United States, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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West Des Moines, Iowa, United States, 50266-7700
- Methodist West Hospital
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West Des Moines, Iowa, United States, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Chanute, Kansas, United States, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, United States, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, United States, 67042
- Cancer Center of Kansas - El Dorado
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Fort Scott, Kansas, United States, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, United States, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, United States, 67068
- Cancer Center of Kansas-Kingman
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Lawrence, Kansas, United States, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, United States, 67905
- Cancer Center of Kansas-Liberal
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Manhattan, Kansas, United States, 66502
- Cancer Center of Kansas-Manhattan
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McPherson, Kansas, United States, 67460
- Cancer Center of Kansas - McPherson
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Newton, Kansas, United States, 67114
- Cancer Center of Kansas - Newton
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Parsons, Kansas, United States, 67357
- Cancer Center of Kansas - Parsons
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Pratt, Kansas, United States, 67124
- Cancer Center of Kansas - Pratt
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Salina, Kansas, United States, 67401
- Cancer Center of Kansas - Salina
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Wellington, Kansas, United States, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, United States, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, United States, 67214
- Cancer Center of Kansas - Wichita
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Wichita, Kansas, United States, 67208
- Associates In Womens Health
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Wichita, Kansas, United States, 67214
- Wichita NCI Community Oncology Research Program
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Wichita, Kansas, United States, 67214
- Via Christi Regional Medical Center
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Winfield, Kansas, United States, 67156
- Cancer Center of Kansas - Winfield
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Hematology/Oncology Clinic LLP
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New Orleans, Louisiana, United States, 70112
- Tulane University Health Sciences Center
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Maine
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Portland, Maine, United States, 04102
- Maine Medical Center-Bramhall Campus
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Scarborough, Maine, United States, 04074
- Maine Medical Center- Scarborough Campus
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Maryland
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Elkton, Maryland, United States, 21921
- Union Hospital of Cecil County
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Massachusetts
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Springfield, Massachusetts, United States, 01199
- Baystate Medical Center
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Michigan
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Ann Arbor, Michigan, United States, 48106-0995
- Saint Joseph Mercy Hospital
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Ann Arbor, Michigan, United States, 48106
- Michigan Cancer Research Consortium NCORP
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Battle Creek, Michigan, United States, 49017
- Bronson Battle Creek
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Big Rapids, Michigan, United States, 49307
- Spectrum Health Big Rapids Hospital
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Dearborn, Michigan, United States, 48124
- Beaumont Hospital-Dearborn
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Detroit, Michigan, United States, 48236
- Saint John Hospital and Medical Center
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Flint, Michigan, United States, 48502
- Hurley Medical Center
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Flint, Michigan, United States, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, United States, 49503
- Spectrum Health at Butterworth Campus
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Grand Rapids, Michigan, United States, 49503
- Mercy Health Saint Mary's
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Grand Rapids, Michigan, United States, 49503
- Cancer Research Consortium of West Michigan NCORP
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Jackson, Michigan, United States, 49201
- Allegiance Health
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Lansing, Michigan, United States, 48912
- Sparrow Hospital
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Livonia, Michigan, United States, 48154
- Saint Mary Mercy Hospital
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Muskegon, Michigan, United States, 49444
- Mercy Health Mercy Campus
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Niles, Michigan, United States, 49120
- Lakeland Community Hospital
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Pontiac, Michigan, United States, 48341
- Saint Joseph Mercy Oakland
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Port Huron, Michigan, United States, 48060
- Lake Huron Medical Center
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Reed City, Michigan, United States, 49677
- Spectrum Health Reed City Hospital
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Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital-Royal Oak
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Saginaw, Michigan, United States, 48601
- Saint Mary's of Michigan
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Saint Joseph, Michigan, United States, 49085
- Marie Yeager Cancer Center
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Saint Joseph, Michigan, United States, 49085
- Lakeland Hospital
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Traverse City, Michigan, United States, 49684
- Munson Medical Center
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Troy, Michigan, United States, 48098
- William Beaumont Hospital - Troy
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Warren, Michigan, United States, 48093
- Saint John Macomb-Oakland Hospital
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Minnesota
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Burnsville, Minnesota, United States, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, United States, 55433
- Mercy Hospital
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Edina, Minnesota, United States, 55435
- Fairview-Southdale Hospital
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Fridley, Minnesota, United States, 55432
- Unity Hospital
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Hutchinson, Minnesota, United States, 55350
- Hutchinson Area Health Care
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Maplewood, Minnesota, United States, 55109
- Saint John's Hospital - Healtheast
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Maplewood, Minnesota, United States, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, United States, 55407
- Abbott-Northwestern Hospital
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Minneapolis, Minnesota, United States, 55454
- Health Partners Inc
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota/Masonic Cancer Center
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New Ulm, Minnesota, United States, 56073
- New Ulm Medical Center
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Robbinsdale, Minnesota, United States, 55422
- North Memorial Medical Health Center
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
Saint Louis Park, Minnesota, United States, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Louis Park, Minnesota, United States, 55416
- Metro Minnesota Community Oncology Research Consortium
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Saint Paul, Minnesota, United States, 55101
- Regions Hospital
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Saint Paul, Minnesota, United States, 55102
- United Hospital
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Shakopee, Minnesota, United States, 55379
- Saint Francis Regional Medical Center
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Stillwater, Minnesota, United States, 55082
- Lakeview Hospital
-
Waconia, Minnesota, United States, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, United States, 56201
- Rice Memorial Hospital
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Woodbury, Minnesota, United States, 55125
- Minnesota Oncology Hematology PA-Woodbury
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Mississippi
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Jackson, Mississippi, United States, 39216
- Saint Dominic-Jackson Memorial Hospital
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Missouri
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Rolla, Missouri, United States, 65401
- Saint John's Clinic-Rolla-Cancer and Hematology
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Saint Louis, Missouri, United States, 63141
- Mercy Hospital Saint Louis
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Springfield, Missouri, United States, 65804
- Cancer Research for the Ozarks NCORP
-
Springfield, Missouri, United States, 65807
- CoxHealth South Hospital
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Springfield, Missouri, United States, 65804
- Mercy Hospital Springfield
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Montana
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Billings, Montana, United States, 59101
- Billings Clinic Cancer Center
-
Billings, Montana, United States, 59101
- Saint Vincent Healthcare
-
Billings, Montana, United States, 59102
- Montana Cancer Consortium NCORP
-
Bozeman, Montana, United States, 59715
- Bozeman Deaconess Hospital
-
Butte, Montana, United States, 59701
- Saint James Community Hospital and Cancer Treatment Center
-
Great Falls, Montana, United States, 59405
- Benefis Healthcare- Sletten Cancer Institute
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Helena, Montana, United States, 59601
- Saint Peter's Community Hospital
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Kalispell, Montana, United States, 59901
- Kalispell Regional Medical Center
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Missoula, Montana, United States, 59802
- Saint Patrick Hospital - Community Hospital
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Nevada
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Las Vegas, Nevada, United States, 89169
- Women's Cancer Center of Nevada
-
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- University of New Mexico Cancer Center
-
Albuquerque, New Mexico, United States, 87106
- Southwest Gynecologic Oncology Associates Inc
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Las Cruces, New Mexico, United States, 88011
- Memorial Medical Center - Las Cruces
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New York
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Brooklyn, New York, United States, 11203
- State University of New York Downstate Medical Center
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
-
Stony Brook, New York, United States, 11794
- Stony Brook University Medical Center
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Charlotte, North Carolina, United States, 28204
- Novant Health Presbyterian Medical Center
-
Hendersonville, North Carolina, United States, 28792
- Park Ridge Hospital Breast Health Center
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Wilmington, North Carolina, United States, 28401
- New Hanover Regional Medical Center/Zimmer Cancer Center
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Winston-Salem, North Carolina, United States, 27104
- Southeast Clinical Oncology Research (SCOR) Consortium NCORP
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Ohio
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Akron, Ohio, United States, 44304
- Summa Akron City Hospital/Cooper Cancer Center
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Cleveland, Ohio, United States, 44106
- Case Western Reserve University
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, United States, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital
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Columbus, Ohio, United States, 43214
- Riverside Methodist Hospital
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Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
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Mayfield Heights, Ohio, United States, 44124
- Hillcrest Hospital Cancer Center
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Mentor, Ohio, United States, 44060
- Lake University Ireland Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
-
Tulsa, Oklahoma, United States, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
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Pennsylvania
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Abington, Pennsylvania, United States, 19001
- Abington Memorial Hospital
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Bryn Mawr, Pennsylvania, United States, 19010
- Bryn Mawr Hospital
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Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center
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Hazleton, Pennsylvania, United States, 18201
- Geisinger Medical Center-Cancer Center Hazleton
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Paoli, Pennsylvania, United States, 19301
- Paoli Memorial Hospital
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State College, Pennsylvania, United States, 16801
- Geisinger Medical Group
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Wilkes-Barre, Pennsylvania, United States, 18711
- Geisinger Wyoming Valley/Henry Cancer Center
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Wynnewood, Pennsylvania, United States, 19096
- Lankenau Medical Center
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Wynnewood, Pennsylvania, United States, 19096
- Main Line Health NCORP
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Rhode Island
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Providence, Rhode Island, United States, 02905
- Women and Infants Hospital
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South Carolina
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Anderson, South Carolina, United States, 29621
- AnMed Health Cancer Center
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Greenville, South Carolina, United States, 29601
- Saint Francis Hospital
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Greer, South Carolina, United States, 29651
- Gibbs Cancer Center-Pelham
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Spartanburg, South Carolina, United States, 29303
- Spartanburg Medical Center
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South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Avera Cancer Institute
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Texas
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Dallas, Texas, United States, 75235
- Parkland Memorial Hospital
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Dallas, Texas, United States, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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Houston, Texas, United States, 77030
- Memorial Hermann Texas Medical Center
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Temple, Texas, United States, 76508
- Scott and White Memorial Hospital
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Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital and Clinics
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Marshfield, Wisconsin, United States, 54449
- Marshfield Clinic
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Milwaukee, Wisconsin, United States, 53226
- Froedtert and The Medical College of Wisconsin
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Milwaukee, Wisconsin, United States, 53215
- Aurora Saint Luke's Medical Center
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New Richmond, Wisconsin, United States, 54017
- Cancer Center of Western Wisconsin
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West Allis, Wisconsin, United States, 53227
- Aurora West Allis Medical Center
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Wyoming
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Casper, Wyoming, United States, 82609
- Rocky Mountain Oncology
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Sheridan, Wyoming, United States, 82801
- Welch Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients will be registered into three distinct groupings, and each group will be analyzed as a separate study:
- Patients who will undergo or have undergone hysterectomy/bilateral salpingo-oophorectomy (BSO) and pelvic lymphadenectomy +/- para-aortic node sampling via open or laparoscopic technique for clinical stage I-II or surgical stage I-III uterine carcinoma, including those receiving postoperative adjuvant therapy; patients enrolling after surgery may have a pathologic stage of I-III OR
- Patients who will undergo or have undergone radical hysterectomy or trachelectomy and pelvic lymphadenectomy +/- para-aortic node sampling via open or laparoscopic technique for clinical stage IA-IIA cervical carcinoma, including those receiving postoperative adjuvant therapy OR
- Patients with vulvar cancer who will undergo or have undergone definitive surgery for primary stage I-IV vulvar cancer who will or have received a radical vulvectomy or radical local excision with concurrent unilateral or bilateral inguinal or inguinal-femoral lymphadenectomy; patients who are going to receive multi-modality therapy (radiation +/-chemotherapy) after undergoing surgery are eligible; patients may undergo sentinel node mapping as long as it is followed by a full lymphadenectomy; (note: enrollment of vulvar patients was closed on June 9, 2014; no vulvar patients will be enrolled after closure of this arm)
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
- Patients must have a serum albumin level of >= 3.0 within 14 days of entry
- Surgery must occur within 5 business days before study entry or within eight weeks after study entry
Exclusion Criteria:
- Patients with any prior clinical history of lower extremity lymphedema
- Patients who have a history of congestive heart failure, chronic renal disease, or chronic liver disease
- Patients with a prior history of chronic lower extremity swelling
- Patients with a Gynecologic Oncology Group (GOG) performance grade of 3 or 4
- Patients with a history of other invasive malignancies if their previous cancer treatment included any of the surgical procedures
- Patients who have had prior lower extremity vascular surgery (arterial or venous)
- Patients who have had prior pelvic, abdominal, inguinal, or lower extremity radiation therapy
- Patients who have had or are going to receive another elective surgery during the same operative event as their pelvic (cervical or uterine cancers) or inguinal (vulvar) lymphadenectomy
- Vulvar patients, from June 9, 2014 on
- Patients cannot be enrolled on the trial unless there is at least one person at the participating site who has been trained in performing limb measurements
- Patients who do not undergo or have not undergone the lymphadenectomy portion of the procedure
- Patients who enter the study and then undergo sentinel node biopsy without the intention of undergoing complete lymphadenectomy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Supportive care (lymphedema assessment)
Patients with vulvar cancer undergo a radical vulvectomy or hemi-vulvectomy followed immediately by an ipsilateral or bilateral inguinal-femoral lymphadenectomy. (Closed to accrual as of June 9, 2014) Patients with cervical cancer undergo a radical hysterectomy or trachelectomy and bilateral pelvic lymphadenectomy +/- para-aortic nodal sampling via vaginal, laparoscopic, or open route. Patients with endometrial cancer undergo a laparoscopic-assisted vaginal hysterectomy, a total laparoscopic hysterectomy, or total abdominal hysterectomy with pelvic lymphadenectomy +/- para-aortic node sampling. Patients undergo limb measurements at baseline, weeks 4-6, and at 3, 6, 9, 12, 18, and 24 months. |
Ancillary studies
Other Names:
Ancillary studies
Undergo surgery
Undergo lymphadenectomy
Undergo lymphedema assessment
Undergo surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of lymphedema, assessed through volumetric measurements using serial circumferential measurements performed from 10 cm above the heel to the inguinal crease at 10 cm intervals
Time Frame: Up to 24 months
|
A competing risks analysis will be required to estimate the cumulative incidence of lymphedema.
Transition probabilities in the Markov Chain will be estimated by simple proportions, ignoring covariates, to address this primary objective.
Confidence intervals for the cumulative incidence of lymphedema then will be computed using the Delta Method, utilizing the fact that the transition proportions have and asymptotic multivariate normal distribution.
|
Up to 24 months
|
Risk factors for the development of lower extremity lymphoma in patients with endometrial cancers
Time Frame: Up to 24 months
|
If risk factors are identified, a model will be developed to predict the level of risk (low, moderate, high) of lymphedema following gynecologic cancer treatment overall, and following treatment for endometrial cancer specifically.
The predictive power of the models for these rates will be assessed.
|
Up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient self-reported symptoms
Time Frame: Up to 24 months
|
Whether the patient self-reported symptoms are associated with the development of lymphedema wit be explored.
|
Up to 24 months
|
Quality of life
Time Frame: Up to 24 months
|
As measured by the FACT QOL scale, psychological adjustment as measured by the Impact of Events Subscale (IES), and FACIT body image items, physical disability as measured by the Lower Extremity Functional Scale -(LEFS) and PROs of physical health status/function (sexual), as measured by FACT-FW; FACIT & PROMIS.
|
Up to 24 months
|
Risk factors for the development of lower extremity lymphoma in patients with cervical cancers
Time Frame: Up to 24 months
|
If risk factors are identified, a model will be developed to predict the level of risk (low, moderate, high) of lymphedema following gynecologic cancer treatment overall, and following treatment for endometrial cancer specifically.
The predictive power of the models for these rates will be assessed.
|
Up to 24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard Barakat, NRG Oncology
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GOG-0244 (OTHER: CTEP)
- UG1CA189867 (U.S. NIH Grant/Contract)
- U10CA101165 (U.S. NIH Grant/Contract)
- NCI-2011-01932 (REGISTRY: CTRP (Clinical Trial Reporting Program))
- CDR0000646813
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Clinical Trials on Lymphedema
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Lymphatica Medtech SATerminatedLymphedema of Upper Limb | Lymphedema, Secondary | Lymphedema, Lower Limb | Lymphedema of Leg | Lymphedema ArmSwitzerland
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Tactile MedicalVanderbilt University Medical CenterRecruitingLymphedema | Lymphedema, Secondary | Lymphedema; Surgical | Lymphedema of Face | Lymphedema Due to RadiationUnited States
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ThuasneUniversity Hospital, Tours; Delta ConsultantsCompletedLymphedema, Secondary | Lymphedema of Leg | Lymphedema Congenital | Lymphedema PrimaryFrance
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Maastricht University Medical CenterRadboud University Medical Center; Erasmus Medical CenterRecruitingLymphedema of Upper Limb | Lymphedema, Secondary | Lymphedema, Lower Limb | Lymphedema of Leg | Lymphedema ArmNetherlands
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Odense University HospitalDanish Cancer SocietyActive, not recruitingPathologic Processes | Neoplasms | Skin Diseases | Lymphatic Diseases | Postoperative Complications | Breast Cancer | Breast Diseases | Lymphedema | Breast Neoplasm | Surgery | Secondary Lymphedema | Breast Cancer Lymphedema | Lymphedema, Breast Cancer | Lymphedema of Upper Limb | Lymphedema Arm | Iatrogenic Lymphedema | A... and other conditionsDenmark
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Swansea Bay University Health BoardSwansea University; Huntleigh Healthcare Ltd; Lymphoedema Wales Clinical NetworkCompleted
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ResMedLymphatic Solutions, LLCCompletedLymphedema | Lymphedema, Secondary | Lymphedema, Lower Limb | Lymphedema of Leg | Lymphedema PrimaryUnited States
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University of OttawaMcGill University; Horizon Health Network; University of New Brunswick; New Brunswick...UnknownLymphedema of Upper Limb | Mastectomy Related Lymphedema | Lymphedema of Lower Extremity
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Odense University HospitalZealand University Hospital; Vejle Hospital; Herlev and Gentofte HospitalRecruitingLymphedema | Breast Cancer Lymphedema | Lymphedema, Breast Cancer | Lymphedema of Upper Limb | Lymphedema, Secondary | Lymphedema Arm | Lymphedema; SurgicalDenmark
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University Hospital, MontpellierCompletedPrimary Lymphedema Secondary LymphedemaFrance
Clinical Trials on Quality-of-Life Assessment
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Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol Specific | Malignant NeoplasmUnited States
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Children's Oncology GroupNational Cancer Institute (NCI)RecruitingChildhood Malignant NeoplasmUnited States, Canada, Puerto Rico, Australia, New Zealand
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
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Wake Forest University Health SciencesWithdrawnLung Metastases | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Recurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma
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City of Hope Medical CenterNational Cancer Institute (NCI)Recruiting
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 InfectionUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 InfectionUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | Neuropathy | COVID-19 InfectionUnited States
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M.D. Anderson Cancer CenterActive, not recruitingCervical Carcinoma | Endometrial Carcinoma | Vaginal Carcinoma | Malignant Female Reproductive System Neoplasm | Vulvar CarcinomaUnited States
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingMetastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 and other conditionsUnited States