Intraoperative Mapping of Regional Lymphatics Draining the Primary Site of Melanoma Using Isosulfan Blue
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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 |
|---|
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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 |
- 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 |
|---|
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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
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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 |
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.
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| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| 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:
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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:
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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 May 19, 2013