CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 74 enrolled
Drug / intervention
Sentinel Node Biopsyprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00315159
NCT00315159N/ACompleted

Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients With Sentinel Lymph Nodes Determined to be Negative for Metastatic Disease.

Women and Infants Hospital of Rhode Island·interventional·Posted Apr 17, 2006·Updated Jan 12, 2015

In Brief

A clinical study evaluating Sentinel Node Biopsy for Vulvar Cancer. Completed, enrolled 74 participants across 1 site.

Detailed 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 undergo a sentinel lymph node dissection as well as resection of the primary tumor on the vulva. Patients who are determined to have sentinel nodes that are negative for metastatic disease will not receive a full groin dissection. Patients who have sentinel lymph nodes that contain metastasis will undergo a complete inguinal dissection. The study will evaluate the long-term outcomes in patients who receive only a sentinel lymph node dissection without a complete dissection. All patients entered onto the study will have a biopsy proven squamous cell carcinoma of the vulva. Each patient will be enrolled by a Gynecologic Oncologist practicing out of Women \& Infants Hospital

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvar Cancer
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 17, 2006
Enrollment StartAug 1, 2003
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10.8 yearsPosted 20.2 years ago

Interventions

Sentinel Node Biopsyprocedure

Inguinal sentinel node biopsy will be performed.