Intraoperative Mapping of Regional Lymphatics Draining the Primary Site of Melanoma Using Isosulfan Blue

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00581698
First received: December 21, 2007
Last updated: September 14, 2009
Last verified: September 2009
  Purpose

The purpose of this study is to determine whether we can consistently identify the first lymph node (the "sentinel node") draining your melanoma.


Condition
Melanoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intraoperative Mapping of Regional Lymphatics Draining the Primary Site of Melanoma Using Isosulfan Blue

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • This is a trial to assess the feasibility of the technique of identifying the sentinel node using the technique of lymphatic mapping as described by Morton. The primary endpoint of the trial will be success or failure in identifying the sentinel node. [ Time Frame: 18 years 1 month ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

tissue (lymph node)


Enrollment: 876
Study Start Date: January 1991
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Surgical
Patients with primary melanomas Clark III and Breslow thickness > 1 mm, or Clark IV-V and any Breslow thickness, and clinically negative regional nodes

Detailed Description:

The issue of elective lymph node dissection (LND) in the management of melanoma patients with clinically negative nodes remains controversial. The concept of elective LND is attractive because it provides the opportunity to detect and remove occult micrometastases before they become clinically apparent. Numerous retrospective analyses have consistently shown a 15-20% long term survival advantage in patients undergoing elective LND who are found to have positive nodes, compared to those undergoing therapeutic LND for clinically positive nodes. The majority of patients undergoing elective LND however, do not have lymph node involvement, and the impact of removal of these negative nodes on the survival of these patients is unknown. The substantial morbidity of these procedures has led to the conduct of a number of important prospective randomized trials designed to define the impact of elective LND on the survival of patients with clinically node negative melanoma. In 1982, the World Health Organization reported on the end results of 553

The primary objective of this protocol is to establish the feasibility of lymph node mapping, using preoperative lymphoscintigraphy and intraoperative blue dye injection to detect the sentinel node in patients at risk for regional lymph node metastasis from their primary melanoma.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with primary melanomas Clark III and Breslow thickness > 1 mm, or Clark IV-V and any Breslow thickness, and clinically negative regional nodes. Patients with a resectable solitary intransit metastasis and clinically negative nodes will be considered for entry on to this protocol on an individual basis.

Criteria

Inclusion Criteria:

  • primary melanomas Clark III and Breslow thickness > 1 mm, or Clark IV-V and any Breslow thickness
  • clinically negative regional nodes

Exclusion Criteria:

  • previous definitive wide local excision of the primary melanoma with skin graft
  • an inflammatory lesion in the area of the primary melanoma that is likely to drain to the same nodal basin
  • pregnancy
  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: NCT00581698

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Daniel Coit, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Daniel Coit, MD, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00581698     History of Changes
Other Study ID Numbers: 91-015
Study First Received: December 21, 2007
Last Updated: September 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Melanoma
Negative regional lymph nodes
Primary melanomas Clark III and Breslow thickness > 1 mm, or Clark
IV-V and any Breslow thickness, and clinically negative regional nodes

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 26, 2014