Prospective Study of Melastatin Expression in Predicting the Risk for Developing Local Regional Metastases of Primary Melanoma
18 Years
N/A
Both
Cutaneous Melanoma
Trial Information
Prospective Study of Melastatin Expression in Predicting the Risk for Developing Local Regional Metastases of Primary 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary stage I or II melanoma
- Must be planning to undergo a sentinel lymph node biopsy or an elective lymph node
dissection of an anatomic draining region from the index primary melanoma within 45
days
- The following tissue blocks must be available:
- Primary tumor tissue taken from region of greatest Breslow thickness
- One of each sentinel node or one representative block from each lymph node
obtained at elective lymph node dissection or therapeutic lymphadenectomy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- No other active malignancy except basal cell skin cancer, carcinoma in situ of the
cervix, or history of any other primary malignancy, including primary melanoma
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Diagnostic
Outcome Measure:
Correlation of melastatin expression and involvement of local regional lymph nodes by pathology prospectively
Safety Issue:
No
Principal Investigator
F. Stephen Hodi, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000257230
NCT ID:
NCT00049010
Start Date:
September 2002
Completion Date:
October 2009
Related Keywords:
- Cutaneous Melanoma
- stage I melanoma
- stage II melanoma
- Melanoma
- Skin Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Rhode Island Hospital | Providence, Rhode Island 02903 |
| Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
| Fairview University Medical Center - University Campus | Minneapolis, Minnesota 55455 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| Miriam Hospital at Lifespan | Providence, Rhode Island 02906 |
| Brigham and Women's Hospital | Boston, Massachusetts 02115 |
| St. Luke's Hospital | Cedar Rapids, Iowa 52402 |
| Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
| Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene, New Hampshire 03431 |
| Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls, New York 12801 |
| Community General Hospital of Greater Syracuse | Syracuse, New York 13215 |
| Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
| Wilson Medical Center | Wilson, North Carolina 27893-3428 |
| Mountainview Medical | Berlin, Vermont 05602 |
| Danville Regional Medical Center | Danville, Virginia 24541 |
| Commonwealth Hematology-Oncology P.C. - Worcester | Worcester, Massachusetts 01605 |
| Roper St. Francis Cancer Center at Roper Hospital | Charleston, South Carolina 29401 |
| Iowa Blood and Cancer Care | Cedar Rapids, Iowa 52402 |
| Capital Region Cancer Center | Jefferson City, Missouri 65101 |
