Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection
GROINSS-V
GROningen INternational Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study
5 other identifiers
observational
148
2 countries
37
Brief Summary
This research trial studies patients with early-stage vulvar cancer undergoing sentinel lymph node dissection. Sentinel lymph node dissection may have fewer side effects than removing all lymph nodes. Observing patients undergoing sentinel lymph node dissection may help doctors confirm the safety of the procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2011
CompletedFirst Posted
Study publicly available on registry
December 28, 2011
CompletedStudy Start
First participant enrolled
January 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedSeptember 30, 2021
September 1, 2021
10.5 years
December 24, 2011
September 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Safety of sentinel lymph node dissection
Up to 2 years
Study Arms (1)
Observation (observe patients undergoing SLN dissection)
Patients receive standard therapy including sentinel lymph node dissection. Patients are then observed to collect information about treatment and outcomes every 2 months for 2 years.
Interventions
Undergo observation
Eligibility Criteria
You may qualify if:
- Patients must have squamous cell carcinoma with a depth invasion \> 1 mm
- Patients must have T1 or T2 tumors (International Federation of Gynecology and Obstetrics\[FIGO\] staging), \< 4 cm, not encroaching in urethra, vagina, or anus with clinically negative inguinofemoral lymph nodes
- Localization and size of the tumor are such that peri-lesional injection of the tracers at three or four sites is possible
- Preoperative imaging do not show enlarged (\< 1.5 cm) suspicious nodes
- Patients must sign informed consent
You may not qualify if:
- Inoperable tumors with diameter \> 4 cm
- Patients with inguinofemoral lymph nodes, at palpation clinically suspect for metastases, at radiology enlarged (\> 1.5 cm) suspicious groin nodes and with cytologically proven inguinofemoral lymph node metastases
- Patients with multifocal tumors
- Patients who are currently on an investigational drug for the treatment of vulvar cancer are excluded from participation in this trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (37)
University of Arizona Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Jackson Memorial Hospital-Holtz Children's Hospital
Miami, Florida, 33136, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, 60521, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Mercy Health Mercy Campus
Muskegon, Michigan, 49444, United States
Lakeland Community Hospital
Niles, Michigan, 49120, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677, United States
Lakeland Hospital
Saint Joseph, Michigan, 49085, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Overlook Hospital
Summit, New Jersey, 07902, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, 29605, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, 24016, United States
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Slomovitz
NRG Oncology