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

Tracking Information

First Received Date ^ICMJE

November 12, 2002

Last Updated Date

February 6, 2009

Start Date ^ICMJE

September 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Correlation of melastatin expression and involvement of local regional lymph nodes by pathology prospectively [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Correlation of melastatin expression and involvement of local regional lymph nodes by pathology prospectively

Change History

Complete list of historical versions of study NCT00049010 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Relapse-free survival based on visits to medical doctor every 4 months [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Relapse-free survival based on visits to medical doctor every 4 months

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Non-Randomized, Active Control

Condition ^ICMJE

Melanoma (Skin)

Intervention ^ICMJE

Genetic: comparative genomic hybridization
Genetic: cytogenetic analysis
Genetic: fluorescence in situ hybridization
Other: immunohistochemistry staining method

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00049010

Responsible Party

Study ID Numbers ^ICMJE

CDR0000257230, CALGB-500105

Study Sponsor ^ICMJE

Cancer and Leukemia Group B

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

F. Stephen Hodi, MD

Dana-Farber Cancer Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

March 2006

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