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Procedure

Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients.

N/A
Waitlist Available
Led By Richard G Moore, MD
Research Sponsored by Women and Infants Hospital of Rhode Island
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

The purpose of this study is to evaluate a less invasive procedure for the evaluation of the inguinal (groin) nodes in patients with a primary squamous cell carcinoma of the vulva. Each patient will undergo a sentinel lymph node dissection as well as resection of the primary tumor on the vulva. Patients who are determined to have sentinel nodes that are negative for metastatic disease will not receive a full groin dissection. Patients who have sentinel lymph nodes that contain metastasis will undergo a complete inguinal dissection. The study will evaluate the long-term outcomes in patients who receive only a sentinel lymph node dissection without a complete dissection. All patients entered onto the study will have a biopsy proven squamous cell carcinoma of the vulva. Each patient will be enrolled by a Gynecologic Oncologist practicing out of Women \& Infants Hospital

Eligible Conditions
  • Vulvar Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Active Control
Group I: No interventionActive Control1 Intervention
Patients with negative SLN will be followed on no intervention arm

Find a Location

Who is running the clinical trial?

Women and Infants Hospital of Rhode IslandLead Sponsor
114 Previous Clinical Trials
40,276 Total Patients Enrolled
Richard G Moore, MDPrincipal InvestigatorWomen and Infants' Hospital
2 Previous Clinical Trials
725 Total Patients Enrolled
~3 spots leftby Dec 2025