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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Richard Moore, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT00315159
First received: April 13, 2006
Last updated: June 12, 2013
Last verified: June 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ability to detect inguinal sentinel nodes in vulvar cancer patients. [ Time Frame: Three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2003
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Sentinel Node Biopsy
    Inguinal sentinel node biopsy will be performed.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Moore, Richard Moore, M.D., Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT00315159     History of Changes
Other Study ID Numbers: 03-0031
Study First Received: April 13, 2006
Last Updated: June 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on August 18, 2014