Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma



Status:Completed
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/2/2016
Start Date:September 2002
End Date:October 2009

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Prospective Study of Melastatin Expression in Predicting the Risk for Developing Local Regional Metastases of Primary Melanoma

RATIONALE: Diagnostic procedures that analyze surgically-removed tumor tissue and lymph node
samples may help doctors identify patients with melanoma who are at risk for developing
metastatic cancer.

PURPOSE: This clinical trial is studying tumor tissue and lymph node samples to see how well
they work in predicting the development of metastatic cancer in patients with stage I or
stage II melanoma.

OBJECTIVES:

- Correlate degree of melastatin gene expression with risk of developing local regional
metastases in patients with primary stage I or II melanoma.

- Correlate melastatin expression prospectively with event-free survival of these
patients.

OUTLINE: This is a multicenter study.

Melastatin mRNA expression is determined by in situ hybridization using tissue from primary
tumor and lymph nodes. Tissue is also examined by immunohistochemical staining using
antibodies to S-100 and MART-1. Patients do not receive the results of these tests nor do
the results influence individual therapy.

Patients are followed every 4 months for 3.5 years.

PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study within 3.5 years.

1. Histologically documented primary AJCC stage I or II melanoma. Evidence of
ulceration, vertical growth phase, regression, lymphocytic infiltration, vascular
invasion, microscopic satellitosis, and mitotic rate shall be noted.

2. Patients planning to undergo a sentinel lymph node biopsy, or an elective lymph node
dissection of an anatomic draining region from the index primary melanoma.

3. ≥18 years of age

4. Patients must be registered prior to planned surgery. The surgery must be performed
within 45 days following registration.

5. No concurrent active malignancy other than carcinoma in situ of the cervix and basal
cell carcinoma of the skin, or history of any other primary malignancy including
previously primary melanoma.

6. Tissue blocks: one of primary tumor tissue taken from region of greatest Breslow
thickness. Note: If blocks cannot be sent due to institutional policy, slides may be
substituted for the locks per the protocol.
We found this trial at
27
sites
Worcester, Massachusetts 01605
1406
mi
from
Worcester, MA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
1444
mi
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Boston, MA
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115 Business loop 70 w
Columbia, Missouri 65203
(573) 882-2100
Ellis Fischel Cancer Center at University of Missouri - Columbia At Ellis Fischel Cancer Center,...
308
mi
from
Columbia, MO
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One Medical Center Drive
Lebanon, New Hampshire 03756
(603) 653-9000
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center at DHMC in...
1393
mi
from
Lebanon, NH
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
1424
mi
from
Providence, RI
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
974
mi
from
Winston-Salem, NC
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130 Fisher Road
Berlin, Vermont 05602
(802) 225-5400
Mountainview Medical Our medical oncologists, hematologist, and oncology advanced practice nurse, along with other dedicated...
1383
mi
from
Berlin, VT
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Massachusetts General Hospital Cancer Center An integral part of one of the world
1444
mi
from
Boston, MA
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1441
mi
from
Boston, MA
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1356
mi
from
Burlington, VT
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Cedar Rapids, Iowa 52402
440
mi
from
Cedar Rapids, IA
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Cedar Rapids, Iowa 52402
440
mi
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Cedar Rapids, IA
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701 10th St SE
Cedar Rapids, Iowa 52403
(319) 365-4673
Mercy Regional Cancer Center at Mercy Medical Center Hall-Perrine Cancer Center is a part of...
440
mi
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Cedar Rapids, IA
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Charleston, South Carolina 29401
1063
mi
from
Charleston, SC
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609
mi
from
Chicago, IL
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142 S Main St
Danville, Virginia 24541
(434) 799-2100
Danville Regional Medical Center For more than 120 years, Danville Regional Medical Center has been...
1013
mi
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Danville, VA
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100 Park Street
Glens Falls, New York 12801
518.926.1000
Charles R. Wood Cancer Center at Glens Falls Hospital Glens Falls Hospital is the largest...
1320
mi
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Glens Falls, NY
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Goldsboro, North Carolina 27534
1110
mi
from
Goldsboro, NC
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Goldsboro, North Carolina 27534
1114
mi
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Goldsboro, NC
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Jefferson City, Missouri 65101
312
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from
Jefferson City, MO
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1385
mi
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Keene, NH
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552
mi
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Minneapolis, MN
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
1289
mi
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New York, NY
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Providence, Rhode Island 02906
1424
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Providence, RI
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1199
mi
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Syracuse, NY
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1193
mi
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Syracuse, NY
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Wilson, North Carolina 27893
1107
mi
from
Wilson, NC
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