Spots Global Cancer Trial Database for Studying Biological Markers of Fatigue in Women With Residual Invasive Breast Cancer Enrolled on Clinical Trial NSABP-B-45

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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