Clinical trial · Observational
A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Principal Investigator Request
Summary
Brief summary (as posted)
This will be a non-blinded, non-randomized study to further our knowledge of and experience with lymph node surgery. The investigators are interested in documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy (SLNB) with inguinal-femoral lymph node dissection (IFLND). The study will be open at the Winthrop P. Rockefeller Cancer Institute at The University of Arkansas for Medical Sciences (UAMS). Dr. Pamela Stone, Dr.Alexander Burnett, and Dr. Juan Roman will be responsible for accruing subjects to this study. It will be open to all patients presenting to the Winthrop P. Rockefeller Cancer Institute with vulvar cancer requiring lymph node evaluation for the ipsilateral and/or contralateral groin who have not had prior groin surgery or radiation to the groins. Patients must meet inclusion and exclusion criteria to be enrolled.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Routine Leg edema and groin dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Vulvar Cancer
- interventionNames
- Procedure: Routine Leg edema and groin dissection
Primary outcomes (1)
- measure
- Successful Identification of Vulvar Sentinel Lymph Nodes Via Gamma Probe.
- timeFrame
- at time of surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients 18-100 years of age. * All races and ethnicities. * Being seen in the Winthrop P. Rockefeller Cancer Institute for vulvar cancer requiring lymph node evaluation for the ipsilateral or contralateral groin. * Willing participation following informed consent process. Exclusion Criteria: * Has not had prior groin surgery or radiation to the groins. * Any condition the PI or study physician determines that will put the subject at risk during the procedure. * Allergy to blue dye used in lymphatic identification. * Pregnant or breast feeding.
References
Publications (0)
Data not yet available