Studying Biological Markers of Fatigue in Women With Residual Invasive Breast Cancer Enrolled on Clinical Trial NSABP-B-45
Biobehavioral Mechanisms of Fatigue in Patients Treated on NSABP B-45: A Phase III Clinical Trial Comparing Adjuvant Sunitinib Malate to Placebo in Women With Residual Invasive Breast Cancer Following Neoadjuvant Chemotherapy
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to fatigue.
PURPOSE: This research study is looking at biological markers of fatigue in women with residual invasive breast cancer enrolled on clinical trial NSABP-B-45.
調査の概要
状態
詳細な説明
OBJECTIVES:
- To collect serial blood specimens at each time point that quality of life and patient-reported outcome assessments are performed in women with residual invasive breast cancer concurrently enrolled on and participating in the Behavioral and Health Outcomes component of clinical trial NSABP-B-45.
- To prepare, separate, and store the blood specimens at the NSABP Serum Bank at Baylor College of Medicine Breast Center into components for future DNA, RNA, and plasma analysis.
- To analyze specific proinflammatory cytokines, genetic polymorphisms, and RNA expression arrays in collaborating laboratories at University of California, Los Angeles (UCLA).
- To examine the association between markers of inflammation and symptoms of fatigue among patients treated with sunitinib malate or placebo on clinical trial NSABP-B-45.
- To examine the relationship between single-nucleotide polymorphisms in the promoter regions of IL-1 and IL-6 and symptoms of fatigue in these patients.
- To examine the relationship between RNA expression profiles and fatigue and compare the pattern of expression in these patients.
OUTLINE: This is a multicenter study.
Patients undergo blood sample collection* at baseline and then at 3, 6, 12, 18, and 24 months for analysis of plasma concentrations of inflammatory biomarkers (IL-1ra, sTNFRII, sIL-6R, and C-reactive protein) by ELISA; DNA polymorphisms in the promoter regions of IL-6 and IL-1 by TaqMan PCR; and RNA gene expression signaling pathways by RT-PCR assays and microarray.
NOTE: *Blood samples are collected at the same time points that the Behavioral and Health Outcomes quality of life and patient-reported outcomes questionnaires are completed on clinical trial NSABP-B-45.
研究の種類
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
DISEASE CHARACTERISTICS:
Diagnosis of residual invasive breast cancer
- Stage II, IIIA, or IIIB disease
- HER2/neu-negative disease
Randomized to receive either sunitinib malate or placebo on clinical trial NSABP-B-45
- Has not started therapy on clinical trial NSABP-B-45
- Has completed baseline Behavioral and Health Outcome questionnaires on clinical trial NSABP-B-45
- Hormone-receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status 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?
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 |
---|
Biological and behavioral predictors of fatigue in breast cancer patients at 12 and 24 months after randomization and initiation of treatment on clinical trial NSABP-B-45
|
Relationship between specific single-nucleotide polymorphisms in the promoter regions of IL-1 and IL-6 and circulating markers of inflammation and symptoms of fatigue
|
Relationship between RNA gene expression pathways and symptoms of fatigue
|
協力者と研究者
研究記録日
主要日程の研究
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 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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