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
  Purpose

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.


Condition Intervention
Vulvar Cancer
Procedure: Routine Leg edema and groin dissection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Successful Identification of Vulvar Sentinel Lymph Nodes Via Gamma Probe. [ Time Frame: at time of surgery ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Gynecology Oncology Clinic

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321697

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01321697     History of Changes
Other Study ID Numbers: 110583
Study First Received: March 22, 2011
Results First Received: June 10, 2013
Last Updated: August 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
Being seen in the Winthrop P. Rockefeller Cancer Institute for vulvar
cancer requiring lymph node evaluation for the ipsilateral or contralateral
groin

Additional relevant MeSH terms:
Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Vulvar Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 02, 2014