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Study of Tumor Tissue From Patients With Melanoma Treated on Clinical Trial EST-1690

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 10, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

RATIONALE: Studying samples of tumor tissue 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 research study is looking at tumor tissue samples from patients with melanoma treated on clinical trial EST-1690.

Condition Intervention
Melanoma (Skin)
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: polymerase chain reaction
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Molecular Prognostic Factor Analysis in Melanoma

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Prognostic role of several biomarkers on the outcome associated with melanoma using IHC
  • Predictive role of these biomarkers in patients undergoing adjuvant interferon alfa therapy
  • Correlation between the intensity of biomarker expression and survival in the observation and interferon-treated groups
  • Prognostic role of these biomarkers on the outcome associated with melanoma using quantitative-PCR
  • Prognostic role of gene expression on the outcome associated with melanoma

Estimated Enrollment: 307
Study Start Date: August 2008
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Detailed Description:


  • To validate the prognostic role of several biomarkers suggested by gene expression profiling and tissue microarray (TMA) studies (e.g., NCOA3, SPP1, and RGS1) on the outcome associated with melanoma in the EST-1690 cohort using IHC analysis.
  • To examine the potential predictive role of such biomarkers in patients undergoing adjuvant interferon alfa therapy.
  • To analyze the correlation between the intensity of biomarker expression and survival of this cohort both in the observation and in the interferon-treated groups.
  • To examine the prognostic role of these biomarkers on the outcome associated with melanoma in the EST-1690 cohort using quantitative-PCR.
  • To isolate RNA from the primary specimens from patients enrolled in the EST-1690 cohort to assess the expression of genes suggested by cDNA microarray and IHC analyses (e.g., NCOA3, SPP1, and RGS1) as prognostic or predictive markers.

OUTLINE: Samples from the EST-1690 cohort are obtained and analyzed for several biomarkers (i.e., NCOA3, SPP1, and RGS1) via immunohistochemistry and quantitative PCR. RNA is isolated from the specimens to assess gene expression via quantitative PCR.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of melanoma

    • No metastatic disease at diagnosis
  • Treated on protocol EST-1690
  • Primary tumor tissue specimens available


  • Not specified


  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00937781

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Mohammed Kashani-Sabet, MD University of California, San Francisco
  More Information Identifier: NCT00937781     History of Changes
Other Study ID Numbers: CDR0000631851
Study First Received: July 10, 2009
Last Updated: July 10, 2009

Keywords provided by National Cancer Institute (NCI):
stage III melanoma
recurrent melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas processed this record on March 28, 2017