S9431: Studying Genes and Immune Response in Tumor Samples From Patients With Locally Advanced or Metastatic Melanoma

NCT00898183 | Completed

• 3 other identifiers: CDR0000078645SWOG-9431U10CA032102
• Study Type: observational
• Target: 91
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This laboratory study is assessing genes and immune response in tumor samples from patients with locally advanced or metastatic melanoma.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (6)

• Correlation of frequency of non-random cytogenetic abnormalities in regional and distant melanoma metastases with clinical outcome

• Correlation of frequency of specific genetic alterations at either the DNA, mRNA, or protein level with clinical outcome

• Host immunologic response to metastatic melanoma (i.e., in vivo pattern of cytokine expression consistent with specific subsets of T helper cells within melanoma deposits)

• Variation and correlation of host immunologic response with site of metastatic disease and/or clinical outcome

• Development of a tissue bank (peripheral blood, sera, and paraffin-embedded tumor blocks)

• Correlation of the most prevalent gene copy alteration observed in metastatic disease with the risk of progression

Interventions

gene expression analysis GENETIC

polymorphism analysis GENETIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of stage III or IV metastatic melanoma * Concurrent enrollment on a SWOG-coordinated melanoma treatment study (within 56 days of registration on this study) OR * Previously enrolled on and eligible for at least 1 SWOG-coordinated melanoma study and scheduled to undergo biopsy/surgery for regional lymph node or disseminated metastatic disease OR * Concurrent enrollment on SWOG-9430 (FISH analysis) 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator
• Eastern Cooperative Oncology Group: collaborator

Related Publications (1)

• 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.

  PMID: 18483359 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Gene Expression Profiling; Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; DNA Fingerprinting; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques

Study Officials

• David M. Gustin, MD

  University of Chicago

  STUDY CHAIR

• John M. Kirkwood, MD

  University of Pittsburgh

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: November 1, 1996
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2007
• Last Updated: June 28, 2018

Record last verified: 2013-02