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

NCT01321697 | Terminated Results

• 1 other identifier: 110583
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvar Cancer

Keywords

Being seen in the Winthrop P. Rockefeller Cancer Institute for vulvar; cancer requiring lymph node evaluation for the ipsilateral or contralateral; groin

Outcome Measures

Primary Outcomes (1)

• Successful Identification of Vulvar Sentinel Lymph Nodes Via Gamma Probe.

  at time of surgery

Study Arms (1)

Vulvar Cancer

Procedure: Routine Leg edema and groin dissection

Interventions

Routine Leg edema and groin dissection PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Gynecology Oncology Clinic

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Limitations and Caveats

Early termination of the study due to investigator decision. No subjects were analyzed.

Results Point of Contact

• Title: Sandy Annis
• Organization: University of Arkansas for Medical Sciences

amannis@uams.edu

5016868274

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 23, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 27, 2013
• Results First Posted: August 27, 2013

Record last verified: 2013-08

Locations

US (1)