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

This study has been terminated.
(Principal Investigator Request)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01321697
First Posted: March 23, 2011
Last Update Posted: August 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Arkansas
March 22, 2011
March 23, 2011
June 10, 2013
August 27, 2013
August 27, 2013
March 2011
June 2012   (Final data collection date for primary outcome measure)
Successful Identification of Vulvar Sentinel Lymph Nodes Via Gamma Probe. [ Time Frame: at time of surgery ]
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Complete list of historical versions of study NCT01321697 on ClinicalTrials.gov Archive Site
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A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer
Not Provided
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.
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
Gynecology Oncology Clinic
Vulvar Cancer
Procedure: 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.
Vulvar Cancer
Intervention: Procedure: Routine Leg edema and groin dissection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
June 2012
June 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01321697
110583
No
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University of Arkansas
University of Arkansas
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Not Provided
University of Arkansas
August 2013