A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer

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Brief Title

A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer


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.
    



Study Type

Observational


Primary Outcome

Successful Identification of Vulvar Sentinel Lymph Nodes Via Gamma Probe.


Condition

Vulvar Cancer

Intervention

Routine Leg edema and groin dissection

Study Arms / Comparison Groups

 Vulvar Cancer
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

7

Start Date

March 2011

Completion Date

June 2012

Primary Completion Date

June 2012

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.
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01321697

Organization ID

110583


Responsible Party

Sponsor

Study Sponsor

University of Arkansas


Study Sponsor

, , 


Verification Date

August 2013