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

Melanoma (Skin) Clinical Trial

Official title:

Molecular Prognostic Factor Analysis in Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937781
• Other study ID #: CDR0000631851
• Secondary ID: ECOG-E1690T1
• Status: Completed
• Phase: N/A
• First received: July 10, 2009
• Last updated: May 16, 2017
• Start date: February 8, 2011
• Est. completion date: August 8, 2011

Study information

• Verified date: May 2017
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: August 8, 2011
• Est. primary completion date: August 8, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Genetic:
• RNA analysis

• gene expression analysis

• microarray analysis

• polymerase chain reaction

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ECOG-ACRIN Cancer Research Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognostic role of several biomarkers on the outcome associated with melanoma using IHC		1 month