Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma
NCT ID: NCT00049010
Last Updated: 2016-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
314 participants
INTERVENTIONAL
2002-09-30
2009-10-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
DIAGNOSTIC
Study Groups
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Group 1
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.
comparative genomic hybridization
cytogenetic analysis
fluorescence in situ hybridization
immunohistochemistry staining method
Interventions
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comparative genomic hybridization
cytogenetic analysis
fluorescence in situ hybridization
immunohistochemistry staining method
Eligibility Criteria
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Inclusion Criteria
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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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F. Stephen Hodi, MD
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Locations
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University of Chicago Cancer Research Center
Chicago, Illinois, United States
Iowa Blood and Cancer Care
Cedar Rapids, Iowa, United States
St. Luke's Hospital
Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Commonwealth Hematology-Oncology P.C. - Worcester
Worcester, Massachusetts, United States
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
Capital Region Cancer Center
Jefferson City, Missouri, United States
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, United States
Community General Hospital of Greater Syracuse
Syracuse, New York, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Wayne Radiation Oncology
Goldsboro, North Carolina, United States
Wilson Medical Center
Wilson, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Miriam Hospital at Lifespan
Providence, Rhode Island, United States
Roper St. Francis Cancer Center at Roper Hospital
Charleston, South Carolina, United States
Mountainview Medical
Berlin Corners, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Danville Regional Medical Center
Danville, Virginia, United States
Countries
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Other Identifiers
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CALGB-500105
Identifier Type: -
Identifier Source: secondary_id
CDR0000257230
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-500105
Identifier Type: -
Identifier Source: org_study_id
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