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Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00315159
First Posted: April 17, 2006
Last Update Posted: January 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Richard G. Moore, MD, Women and Infants Hospital of Rhode Island
  Purpose
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

Condition Intervention
Vulvar Cancer Procedure: Sentinel Node Biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conservative Management With Isolated Sentinel Lymph Node Biopsy in Vulvar Cancer Patients With Sentinel Lymph Nodes Determined to be Negative for Metastatic Disease.

Resource links provided by NLM:


Further study details as provided by Richard G. Moore, MD, Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • Determination of inguinal recurrence rates in patients with negative sentinel lymph node biopsy alone. [ Time Frame: Three years ]

Secondary Outcome Measures:
  • Ability to detect inguinal sentinel nodes in vulvar cancer patients. [ Time Frame: Three years ]

Enrollment: 74
Study Start Date: August 2003
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No intervention
Patients with negative SLN will be followed on no intervention arm
Procedure: Sentinel Node Biopsy
Inguinal sentinel node biopsy will be performed.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient of any age 18 years or over.
  2. Biopsy proven squamous cell carcinoma of the vulva.
  3. Depth of invasion 1mm or greater.
  4. Patients with groins clinically negative for nodal metastasis.
  5. Patients that are candidates for groin dissections.

Exclusion Criteria:

  1. Any patient below the age of 18
  2. Patients with clinically suspicious groin nodes for metastatic disease.
  3. Patients with non-squamous cell vulvar lesions.
  4. Depth of invasion less than 1mm.
  5. Patients refusing to sign an informed consent form.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315159


Locations
United States, Rhode Island
Women and Infants' Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Investigators
Principal Investigator: Richard G Moore, MD Women and Infants' Hospital
  More Information

Publications:

Responsible Party: Richard G. Moore, MD, Richard Moore, M.D., Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT00315159     History of Changes
Other Study ID Numbers: 03-0031
First Submitted: April 13, 2006
First Posted: April 17, 2006
Last Update Posted: January 12, 2015
Last Verified: January 2015

Keywords provided by Richard G. Moore, MD, Women and Infants Hospital of Rhode Island:
Squamous
Cell
Carcinoma
Vulva
Sentinel Node

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