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Printer Friendly Page Effectiveness of Lymph Node Mapping to Reduce the Risk of Swelling in the Legs in Patients with Stage I Endometrial Cancer

Effectiveness of Lymph Node Mapping to Reduce the Risk of Swelling in the Legs in Patients with Stage I Endometrial Cancer

Clinicaltrials.gov identifier:
NCT05646316

Treatment
People with stage I endometrial cancer who are having a hysterectomy

Study Contact Information:

For additional information, please contact Dr. Edward Tanner, PI at [email protected]

Effectiveness of Lymph Node Mapping to Reduce the Risk of Swelling in the Legs in Patients with Stage I Endometrial Cancer

About the Study

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 () in patients undergoing a hysterectomy for I endometrial cancer. Standard lymph node dissection removes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby . Sentinel lymph node mapping uses a special dye and camera to look for a specific lymph node most likely to contain cancer cells. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs.

What the Study Involves

Participants will be divided into one of two groups.

Group A: Participants will receive a special dye injected into the vein and undergo lymph node mapping and removal during a hysterectomy. around the uterus may be removed if the mapping and removal cannot be completed. Successful mapping requires no additional removal of .

Group B: Participants will receive a special dye injected into the vein and undergo lymph node mapping and removal during a hysterectomy. Additional around the uterus are removed per standard of care.

Participants in both groups also undergo imaging as needed and optional blood sample collection throughout the study.

After completion of study intervention, participants are followed every 3 months for one year and at 18 and 24 months.

District of Columbia

City: Washington RECRUITING
Facility: George Washington University Medical Center
Contact Info:
202-741-2981
Nicole P. Chappell

Florida

City: Coral Gables RECRUITING
Facility: UM Sylvester Comprehensive Cancer Center at Coral Gables
Contact Info:
305-243-2647
Abdulrahman Sinno

City: Deerfield Beach RECRUITING
Facility: UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Contact Info:
305-243-2647
Abdulrahman Sinno

City: Miami RECRUITING
Facility: University of Miami Miller School of Medicine-Sylvester Cancer Center
Contact Info:
305-243-2647
Abdulrahman Sinno

City: Plantation RECRUITING
Facility: UM Sylvester Comprehensive Cancer Center at Plantation
Contact Info:
305-243-2647
Abdulrahman Sinno

Illinois

City: Chicago RECRUITING
Facility: Northwestern University
Contact Info:
[email protected] 312-695-1301
Emily Hinchcliff

City: Warrenville RECRUITING
Facility: Northwestern Medicine Cancer Center Warrenville
Contact Info:
[email protected] 630-352-5360
Emily Hinchcliff

Indiana

City: Carmel RECRUITING
Facility: IU Health North Hospital
Contact Info:
[email protected] 317-278-5632
Lisa M. Landrum

City: Indianapolis RECRUITING
Facility: Indiana University/Melvin and Bren Simon Cancer Center
Contact Info:
[email protected] 317-278-5632
Lisa M. Landrum

Louisiana

City: Marrero RECRUITING
Facility: West Jefferson Medical Center
Contact Info:
[email protected] 504-210-3539
Tara Castellano

City: Metairie RECRUITING
Facility: East Jefferson General Hospital
Contact Info:
[email protected] 504-210-3539
Tara Castellano

City: New Orleans RECRUITING
Facility: Louisiana State University Health Science Center
Contact Info:
[email protected] 504-210-3539
Tara Castellano

City: New Orleans RECRUITING
Facility: University Medical Center New Orleans
Contact Info:
[email protected] 504-210-3539
Tara Castellano

Maryland

City: Baltimore RECRUITING
Facility: University of Maryland/Greenebaum Cancer Center
Contact Info:
800-888-8823
Gautam G. Rao

Michigan

City: Detroit RECRUITING
Facility: Wayne State University/Karmanos Cancer Institute
Contact Info:
[email protected] 313-576-9790
Robert T. Morris

City: Farmington Hills RECRUITING
Facility: Weisberg Cancer Treatment Center
Contact Info:
[email protected] 313-576-9790
Robert T. Morris

City: Flint RECRUITING
Facility: McLaren Cancer Institute-Flint
Contact Info:
[email protected] 313-576-9790
Robert T. Morris

Minnesota

City: Edina RECRUITING
Facility: Fairview Southdale Hospital
Contact Info:
[email protected] 952-993-1517
Britt K. Erickson

City: Maple Grove RECRUITING
Facility: Fairview Clinics and Surgery Center Maple Grove
Contact Info:
[email protected] 952-993-1517
Britt K. Erickson

City: Maplewood RECRUITING
Facility: Saint John's Hospital - Healtheast
Contact Info:
[email protected] 952-993-1517
Britt K. Erickson

City: Princeton RECRUITING
Facility: Fairview Northland Medical Center
Contact Info:
[email protected] 952-993-1517
Britt K. Erickson

City: Saint Paul RECRUITING
Facility: Regions Hospital
Contact Info:
[email protected] 952-993-1517
Britt K. Erickson

City: Wyoming RECRUITING
Facility: Fairview Lakes Medical Center
Contact Info:
[email protected] 952-993-1517
Britt K. Erickson

Missouri

City: Springfield RECRUITING
Facility: Mercy Hospital Springfield
Contact Info:
417-269-4520
Jay W. Carlson

Nebraska

City: Omaha RECRUITING
Facility: University of Nebraska Medical Center
Contact Info:
[email protected] 402-559-6941
Kerry J. Rodabaugh

Nevada

City: Las Vegas RECRUITING
Facility: Women's Cancer Center of Nevada
Contact Info:
[email protected] 702-693-6870
Nicola M. Spirtos

Oklahoma

City: Oklahoma City RECRUITING
Facility: University of Oklahoma Health Sciences Center
Contact Info:
[email protected] 405-271-8777
Joan L. Walker

Pennsylvania

City: Bryn Mawr RECRUITING
Facility: Bryn Mawr Hospital
Contact Info:
[email protected] 484-476-2649
Deric C. Savior

City: Paoli RECRUITING
Facility: Paoli Memorial Hospital
Contact Info:
[email protected] 484-476-2649
Deric C. Savior

City: Wynnewood RECRUITING
Facility: Lankenau Medical Center
Contact Info:
[email protected] 484-476-2649
Deric C. Savior

Rhode Island

City: Providence RECRUITING
Facility: Women and Infants Hospital
Contact Info:
401-274-1122
Matthew T. Oliver

Texas

City: Dallas RECRUITING
Facility: Parkland Memorial Hospital
Contact Info:
[email protected] 214-590-5582
Jayanthi S. Lea

City: Dallas RECRUITING
Facility: UT Southwestern/Simmons Cancer Center-Dallas
Contact Info:
[email protected] 214-648-7097
Jayanthi S. Lea

City: Richardson RECRUITING
Facility: UT Southwestern Clinical Center at Richardson/Plano
Contact Info:
[email protected] 972-669-7044
Jayanthi S. Lea

Virginia

City: Charlottesville RECRUITING
Facility: University of Virginia Cancer Center
Contact Info:
[email protected] 434-243-6303
Kari L. Ring

This Study is Open To:

People, aged 18 years and older, who meet the following criteria:

  • Diagnosed with I endometrial cancer and plan to have a laparoscopic or robotic hysterectomy and lymphatic assessment as part of their primary management.
  • Speak English or Spanish.
This Study is Not Open To:

People who are under the age of 18 and who:

  • Had chemotherapy or for endometrial cancer except progestin-containing therapies and levonorgestrel-containing intrauterine device (IUD).
  • Had radiation to the pelvis, groin, or lower extremities or surgery to in the pelvis or groin area.
  • Will undergo another surgery at the same time as endometrial surgery.
  • Have another disease or medical condition such as lower extremity or chronic lower extremity swelling.
  • Have lower extremity or pelvic deep venous thromboembolism (occurs when a blood clot breaks off and travels through the bloodstream, blocking a blood vessel) or lower extremity cellulitis (a bacterial skin infection) within 90 days of registration.