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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00937781
First Posted: July 13, 2009
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
  Purpose

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
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: Molecular Prognostic Factor Analysis in Melanoma

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):

Primary Outcome Measures:
  • Prognostic role of several biomarkers on the outcome associated with melanoma using IHC [ Time Frame: 1 month ]

Enrollment: 307
Actual Study Start Date: February 8, 2011
Study Completion Date: August 8, 2011
Primary Completion Date: August 8, 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples submitted for research from patients enrolled on E1690
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of melanoma

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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937781


Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
Study Chair: Mohammed Kashani-Sabet, MD University of California, San Francisco
  More Information

Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT00937781     History of Changes
Other Study ID Numbers: CDR0000631851
ECOG-E1690T1
First Submitted: July 10, 2009
First Posted: July 13, 2009
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
stage III melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas