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:

Information provided by (Responsible Party):

University of Arkansas

ClinicalTrials.gov Identifier:

NCT01321697

First received: March 22, 2011

Last updated: June 12, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 22, 2011
Last Updated Date	June 12, 2012
Start Date ^ICMJE	March 2011
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01321697 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer
Official Title ^ICMJE	Not Provided
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 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Gynecology Oncology Clinic
Condition ^ICMJE	Vulvar Cancer
Intervention ^ICMJE	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.
Study Group/Cohort (s)	Vulvar Cancer Intervention: Procedure: Routine Leg edema and groin dissection
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	7
Completion Date	June 2012
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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 and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01321697
Other Study ID Numbers ^ICMJE	110583
Has Data Monitoring Committee	No
Responsible Party	University of Arkansas
Study Sponsor ^ICMJE	University of Arkansas
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Arkansas
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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