Status:
COMPLETED
Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients.
Lead Sponsor:
Women and Infants Hospital of Rhode Island
Conditions:
Vulvar Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate a less invasive procedure for the evaluation of the inguinal (groin) nodes in patients with a primary squamous cell carcinoma of the vulva. Each patient will u...
Detailed Description
Conservative Management with Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients with Sentinel Lymph Nodes Determined to be Negative for Metastatic Disease. Introduction The American Cancer...
Eligibility Criteria
Inclusion
- Patient of any age 18 years or over.
- Biopsy proven squamous cell carcinoma of the vulva.
- Depth of invasion 1mm or greater.
- Patients with groins clinically negative for nodal metastasis.
- Patients that are candidates for groin dissections.
Exclusion
- Any patient below the age of 18
- Patients with clinically suspicious groin nodes for metastatic disease.
- Patients with non-squamous cell vulvar lesions.
- Depth of invasion less than 1mm.
- Patients refusing to sign an informed consent form.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00315159
Start Date
August 1 2003
End Date
May 1 2014
Last Update
January 12 2015
Active Locations (1)
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1
Women and Infants' Hospital of Rhode Island
Providence, Rhode Island, United States, 02905