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Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Sponsor: NRG Oncology
Summary
This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby lymph nodes. Sentinel lymph node mapping uses a special dye and camera to look for cancer that may have spread to nearby lymph nodes. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs.
Official title: A Phase III Trial Of The Impact Of Sentinel Lymph Node Mapping On Patient Reported Lower Extremity Limb Dysfunction In Endometrial Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
428
Start Date
2022-12-07
Completion Date
2026-10-31
Last Updated
2026-03-27
Healthy Volunteers
No
Interventions
Biospecimen Collection
Undergo blood sample collection
Diagnostic Imaging Testing
Undergo imaging
Excisional Biopsy
Undergo sentinel lymph node excision
Indocyanine Green Solution
Given via injection
Minimally Invasive Surgery
Undergo minimally invasive hysterectomy
Pelvic Lymphadenectomy
Undergo pelvic lymphadenectomy
Questionnaire Administration
Ancillary studies
Sentinel Lymph Node Mapping
Undergo sentinel lymph node mapping
Locations (55)
George Washington University Medical Center
Washington D.C., District of Columbia, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
North Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States
Augusta University Medical Center
Augusta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
IU Health North Hospital
Carmel, Indiana, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
West Jefferson Medical Center
Marrero, Louisiana, United States
East Jefferson General Hospital
Metairie, Louisiana, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
UM Upper Chesapeake Medical Center
Bel Air, Maryland, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
McLaren Cancer Institute-Flint
Flint, Michigan, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Fairview Northland Medical Center
Princeton, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
Saint Vincent Healthcare
Billings, Montana, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, United States
Intermountain Health West End Clinic
Billings, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Fred and Pamela Buffett Cancer Center - Kearney
Kearney, Nebraska, United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Women and Infants Hospital
Providence, Rhode Island, United States
Parkland Memorial Hospital
Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Memorial Hermann Texas Medical Center
Houston, Texas, United States
Methodist Willowbrook Hospital
Houston, Texas, United States
Houston Methodist West Hospital
Houston, Texas, United States
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, United States
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, United States
Houston Methodist The Woodlands Hospital
The Woodlands, Texas, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States