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Completed

NCT Number: NCT00897520

Biomarkers in Patients With High-Risk Melanoma Receiving High-Dose Interferon Therapy

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer and predict how patients will respond to treatment.

PURPOSE: This research study is looking at biomarkers in patients with high-risk melanoma receiving high-dose interferon therapy.

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Key information

About this study

OBJECTIVES:

  • To screen serum specimens using a high throughput protein profiling platform that tests for the highest number of known biomarkers (detectable by antibodies) that could be predictors of response to interferon treatment, autoimmunity, and disease outcome in patients with high-risk melanoma undergoing high-dose interferon (IFNa2b) therapy .
  • To compare soluble factors across all patients at each time point (baseline and during therapy).
  • To compare pre-therapy vs post-therapy serum samples from these patients.
  • To assess the kinetics of soluble factors' appearance, persistence, and disappearance during the 12 months of therapy.
  • To assess whether the amount of specific soluble factors in the pre-therapy sample is predictive of response independent of therapy.
  • To correlate statistically significant factors with S100 and autoimmunity in these patients.
  • To confirm the data obtained with the Luminex technology.

OUTLINE: Patients are stratified according to survival (< 2 years vs > 5 years).

Blood samples collected from patients enrolled in E-1694 are analyzed using high throughput protein profiling by ELISA to compare changes in levels of putative biomarkers of interferon alfa-2b, including cytokines and paired receptors, chemokines, cell adhesion molecules, metalloproteinases, angiogenic markers, growth factors, soluble receptors, signal transduction molecules, hormones, and other biomarkers of disease and dysregulated immune processes, at baseline and during therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Diagnosis of high-risk melanoma
  • Receiving interferon alfa-2b therapy in arm II of clinical trial E-1694

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Treatment and study plan

recombinant interferon alfa

Biological

proteomic profiling

Genetic

immunoenzyme technique

Other

laboratory biomarker analysis

Other

Primary outcomes

  1. Serum sample screening via high throughput protein profiling in patients undergoing therapy

    Time frame: 1 month

  2. Comparison of soluble factors

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

ECOG-ACRIN Cancer Research Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

PILOT-high Throughput-protein Profiling Analysis of Sera Collected From E1694 Patients Undergoing HDI (Arm B)

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 12, 2009
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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