Biomarkers in Patients With High-Risk Melanoma Receiving High-Dose Interferon Therapy
PILOT-high Throughput-protein Profiling Analysis of Sera Collected From E1694 Patients Undergoing HDI (Arm B)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:他の
- 時間の展望:回顧
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Serum sample screening via high throughput protein profiling in patients undergoing therapy
時間枠:1 month
|
1 month
|
|
Comparison of soluble factors
時間枠:1 month
|
1 month
|
協力者と研究者
捜査官
- スタディチェア:Monica Panelli, PhD、University of Pittsburgh
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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