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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:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01321697
First received: March 22, 2011
Last updated: August 23, 2013
Last verified: August 2013

March 22, 2011
August 23, 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 ] [ Designated as safety issue: No ]
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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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01321697
110583
No
University of Arkansas
University of Arkansas
Not Provided
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University of Arkansas
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP