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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00049010
First received: November 12, 2002
Last updated: September 27, 2013
Last verified: September 2013

November 12, 2002
September 27, 2013
September 2002
March 2006   (final data collection date for primary outcome measure)
Correlation of melastatin expression and involvement of local regional lymph nodes by pathology prospectively [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00049010 on ClinicalTrials.gov Archive Site
Relapse-free survival based on visits to medical doctor every 4 months [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma
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.

Interventional
Not Provided
Allocation: Non-Randomized
Primary Purpose: Diagnostic
Melanoma (Skin)
  • Genetic: comparative genomic hybridization
  • Genetic: cytogenetic analysis
  • Genetic: fluorescence in situ hybridization
  • Other: immunohistochemistry staining method
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
314
October 2009
March 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00049010
CDR0000257230, U10CA031946, CALGB-500105
No
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: F. Stephen Hodi, MD Dana-Farber Cancer Institute
Alliance for Clinical Trials in Oncology
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP