TriangleNCT01321697 · REGISTRY CONDITION SEARCH
A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- Not reported
- Status at capture
- TERMINATED
- Registry last update
- 2013-08-27
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- 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.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sampling Method
- PROBABILITY_SAMPLE
- sex
- FEMALE
- std Ages
- ADULT
- OLDER_ADULT
- study Population
- Gynecology Oncology Clinic
Treatment arms and interventions
- arm Groups
- intervention Names
- Procedure: Routine Leg edema and groin dissection
- label
- Vulvar Cancer
- interventions
- arm Group Labels
- Vulvar Cancer
- description
- The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
- name
- Routine Leg edema and groin dissection
- type
- PROCEDURE
Study design
- observational Model
- CASE_ONLY
- time Perspective
- PROSPECTIVE
Enrollment
- count
- 7
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Successful Identification of Vulvar Sentinel Lymph Nodes Via Gamma Probe.
- time Frame
- at time of surgery
Full study description
- brief Summary
- 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.
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
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- occurrences
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- end
- 11
- exact text
- NCT01321697
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Vulvar Cancer
- query disease state id
- ds-vulvar-cancer
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-vulvar-cancer-000.json
- source file sha256
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- source json pointer
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- source kind
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- source record id
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- source string sha256
- 5d595ffa5015f3e376dedb51c99dd5460e8dc5a1491e569dc0f25e8067feba13
Preserved source evidence · Not medical advice