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| ID | Type | Description | Link |
|---|---|---|---|
| NIH P01 CA029605 |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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Subjects must be diagnosed with melanoma. All subjects receive Wide Excision (WEX) of their melanoma. If the melanoma meets study requirements, the subject is randomized to receive either (1) no further surgical procedures as part of the study or (2) a Selective Lymphadenectomy with the possibility of a Complete Lymphadenectomy. Subjects are then followed for 10 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WEX only | Active Comparator |
| |
| WEX + SLND | Active Comparator |
| |
| WEX+SLND+CLND | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentinel Lymph Node Dissection | Procedure | Subject has wide excision and sentinel lymph node dissection for primary melanoma. |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine whether wide excision of the primary with intraoperative lymphatic mapping (LM) followed by selective lymphadenectomy will effectively prolong overall survival compared to wide excision of the primary melanoma alone. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival; Incidence, timing, and anatomic distribution of distant metastases; Morbidity of procedures; Significance of TA90 levels; Incidence of Sentinel Node Metastases (biopsy) vs clinical metastases (observation); Accuracy of LM | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald L Morton, MD | Saint John's Cancer Institute | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17005948 | Result | Morton DL, Thompson JF, Cochran AJ, Mozzillo N, Elashoff R, Essner R, Nieweg OE, Roses DF, Hoekstra HJ, Karakousis CP, Reintgen DS, Coventry BJ, Glass EC, Wang HJ; MSLT Group. Sentinel-node biopsy or nodal observation in melanoma. N Engl J Med. 2006 Sep 28;355(13):1307-17. doi: 10.1056/NEJMoa060992. | |
| 20614193 | Result |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Complete Lymph Node Dissection | Procedure | Subject has wide excision, sentinel lymph node dissection, and complete lymph node dissection (if positive sentinel node found) for primary melanoma. |
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| Wide Excision | Procedure | Subject has wide excision only for primary melanoma. |
|
| Faries MB, Thompson JF, Cochran A, Elashoff R, Glass EC, Mozzillo N, Nieweg OE, Roses DF, Hoekstra HJ, Karakousis CP, Reintgen DS, Coventry BJ, Wang HJ, Morton DL; MSLT Cooperative Group. The impact on morbidity and length of stay of early versus delayed complete lymphadenectomy in melanoma: results of the Multicenter Selective Lymphadenectomy Trial (I). Ann Surg Oncol. 2010 Dec;17(12):3324-9. doi: 10.1245/s10434-010-1203-0. Epub 2010 Jul 8. |
| 22648554 | Result | Howard JH, Thompson JF, Mozzillo N, Nieweg OE, Hoekstra HJ, Roses DF, Sondak VK, Reintgen DS, Kashani-Sabet M, Karakousis CP, Coventry BJ, Kraybill WG, Smithers BM, Elashoff R, Stern SL, Cochran AJ, Faries MB, Morton DL. Metastasectomy for distant metastatic melanoma: analysis of data from the first Multicenter Selective Lymphadenectomy Trial (MSLT-I). Ann Surg Oncol. 2012 Aug;19(8):2547-55. doi: 10.1245/s10434-012-2398-z. Epub 2012 May 31. |
| 24521106 | Derived | Morton DL, Thompson JF, Cochran AJ, Mozzillo N, Nieweg OE, Roses DF, Hoekstra HJ, Karakousis CP, Puleo CA, Coventry BJ, Kashani-Sabet M, Smithers BM, Paul E, Kraybill WG, McKinnon JG, Wang HJ, Elashoff R, Faries MB; MSLT Group. Final trial report of sentinel-node biopsy versus nodal observation in melanoma. N Engl J Med. 2014 Feb 13;370(7):599-609. doi: 10.1056/NEJMoa1310460. |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |