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CompletedNCT00898183Updated Jun 28, 2018

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

An observational study in Melanoma (Skin), sponsored by SWOG Cancer Research Network. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-28.

Sponsored by SWOG Cancer Research Network · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
91
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

OBJECTIVES:

  • 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.

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Conditions studied

  • Melanoma (Skin)

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Keywords

  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
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In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 91 is below the median of 182 across 438 observational studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
91 participants (actual)
Patient registry
No

Interventions

  • Geneticgene expression analysis
  • Geneticpolymorphism analysis
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What researchers measure

Primary outcomes

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

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

  3. 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)

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

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

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 18483359 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00898183
Lead sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), Eastern Cooperative Oncology Group
Responsible party
Sponsor
First posted
May 12, 2009
Start date
Nov 1996
Primary completion
Feb 2006
Completion
Feb 2007
Last update
Jun 28, 2018

Study contacts

David M. Gustin, MD
study chair · University of Chicago
John M. Kirkwood, MD
study chair · University of Pittsburgh

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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