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NCT00315159 · ClinicalTrials.gov registry record · NA
Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients.
A NA study of Vulvar Cancer, sponsored by Women and Infants Hospital of Rhode Island.
- Completed
- Registry status
- NA
- Development phase
- 74
- Enrollment target
- 1
- Study location
NCT00315159 is a NA study of Vulvar Cancer that has completed, run by Women and Infants Hospital of Rhode Island. The registered enrollment target is 74 participants, below the 449-participant average among 17 other Vulvar Cancer trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00315159, a NA study of Vulvar Cancer, has completed, sponsored by Women and Infants Hospital of Rhode Island.
- COMPLETED
- Registry status
- NA
- Development phase
- 74 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- PROCEDURE Sentinel Node Biopsy
Study Locations (1)
Rhode Island
- Women and Infants' Hospital of Rhode Island - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2003-08 |
| Est. Completion | 2014-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00315159
The ClinicalTrials.gov registry entry for NCT00315159 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 449-participant average among 17 other Vulvar Cancer trials with a reported enrollment target (84% lower). The listed sponsor is Women and Infants Hospital of Rhode Island, which has 65 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Vulvar Cancer appearing as the primary indexed condition, and to 1 intervention - of which Sentinel Node Biopsy is the first listed.
NCT00315159 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.
Frequently Asked Questions
What is clinical trial NCT00315159 about?
NCT00315159 is a clinical study titled "Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients.". 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. Pati...
What is the current status of trial NCT00315159?
This trial is currently completed. It is a NA study. The enrollment target is 74 participants. The study started on 2003-08. Estimated completion is 2014-05.
What conditions does trial NCT00315159 study?
This clinical trial studies the following conditions: Vulvar Cancer.
What interventions are being tested in trial NCT00315159?
The interventions under investigation include: Sentinel Node Biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT00315159?
This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00315159 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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