Intraoperative Mapping of Regional Lymphatics Draining the Primary Site of Melanoma Using Isosulfan Blue
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| First Received Date ICMJE | December 21, 2007 | ||||
| Last Updated Date | September 14, 2009 | ||||
| Start Date ICMJE | January 1991 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00581698 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intraoperative Mapping of Regional Lymphatics Draining the Primary Site of Melanoma Using Isosulfan Blue | ||||
| Official Title ICMJE | Intraoperative Mapping of Regional Lymphatics Draining the Primary Site of Melanoma Using Isosulfan Blue | ||||
| Brief Summary | The purpose of this study is to determine whether we can consistently identify the first lymph node (the "sentinel node") draining your melanoma. |
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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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: tissue (lymph node) |
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| 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. |
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| Condition ICMJE | Melanoma | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 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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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 876 | ||||
| Completion Date | September 2009 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00581698 | ||||
| Other Study ID Numbers ICMJE | 91-015 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Daniel Coit, MD, Memorial Sloan-Kettering Cancer Center | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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