Studying Biological Markers of Fatigue in Women With Residual Invasive Breast Cancer Enrolled on Clinical Trial NSABP-B-45
NCT ID: NCT00914043
Last Updated: 2013-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2010-06-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Interventions
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gene expression analysis
microarray analysis
polymerase chain reaction
polymorphism analysis
reverse transcriptase-polymerase chain reaction
biologic sample preservation procedure
enzyme-linked immunosorbent assay
laboratory biomarker analysis
fatigue assessment and management
Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NSABP Foundation Inc
NETWORK
Responsible Party
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Principal Investigators
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Norman Wolmark, MD
Role: PRINCIPAL_INVESTIGATOR
NSABP Foundation Inc
Other Identifiers
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NSABP-B-45.1
Identifier Type: -
Identifier Source: secondary_id
NSABP B-45.1
Identifier Type: -
Identifier Source: org_study_id
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