S9431: Studying Genes and Immune Response in Tumor Samples From Patients With Locally Advanced or Metastatic Melanoma
NCT ID: NCT00898183
Last Updated: 2018-06-28
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
91 participants
OBSERVATIONAL
1996-11-30
2007-02-28
Brief Summary
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PURPOSE: This laboratory study is assessing genes and immune response in tumor samples from patients with locally advanced or metastatic melanoma.
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Detailed Description
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* Characterize the frequency of non-random cytogenetic abnormalities in regional and distant melanoma metastases and explore their association with clinical outcome of patients with metastatic melanoma.
* Characterize the frequency of specific genetic alterations at either the DNA, mRNA, or protein level and explore the association of these abnormalities with clinical outcome in these patients.
* Characterize the host immunologic response to metastatic melanoma by determining whether the in vivo pattern of cytokine expression is consistent with specific subsets of T helper cells within melanoma deposits and to explore whether host immunologic response varies based on the site of metastatic disease and/or correlates with clinical outcome in these patients.
* Obtain peripheral blood, sera, and paraffin embedded tumor blocks from these patients.
* Correlate the most prevalent gene copy alteration observed in metastatic disease with the risk of progression in tissue samples from patients registered on SWOG-9035 (primary melanoma).
OUTLINE: Fresh and snap frozen tumor tissue samples are obtained from biopsy or surgical procedures in the coordinated study. Specimens undergo mRNA and DNA analysis of tumor-related genes and cytokine gene expression. Peripheral blood samples are obtained and processed for sera and mononuclear cell testing. Tumor tissue samples embedded in paraffin or on unstained slides are also obtained.
PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study within 3-4 years.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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gene expression analysis
polymorphism analysis
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS:
Age
* Not specified
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* Not previously enrolled on SWOG-9431
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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David M. Gustin, MD
Role: STUDY_CHAIR
University of Chicago
John M. Kirkwood, MD
Role: STUDY_CHAIR
University of Pittsburgh
References
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Moore SR, Persons DL, Sosman JA, Bobadilla D, Bedell V, Smith DD, Wolman SR, Tuthill RJ, Moon J, Sondak VK, Slovak ML. Detection of copy number alterations in metastatic melanoma by a DNA fluorescence in situ hybridization probe panel and array comparative genomic hybridization: a southwest oncology group study (S9431). Clin Cancer Res. 2008 May 15;14(10):2927-35. doi: 10.1158/1078-0432.CCR-07-4068.
Other Identifiers
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SWOG-9431
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000078645
Identifier Type: -
Identifier Source: org_study_id
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