Vulvar Cancer
Conditions
Keywords
Being seen in the Winthrop P. Rockefeller Cancer Institute for vulvar, cancer requiring lymph node evaluation for the ipsilateral or contralateral, groin
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.
Interventions
PROCEDURERoutine Leg edema and groin dissection
The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
Sponsors
University of Arkansas
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful Identification of Vulvar Sentinel Lymph Nodes Via Gamma Probe. | at time of surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vulvar Cancer Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study Terminated | 7 |
Baseline characteristics
| Characteristic | Vulvar Cancer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Successful Identification of Vulvar Sentinel Lymph Nodes Via Gamma Probe.
Time frame: at time of surgery
Population: Data were not collected/analyzed due to study termination.