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

Withdrawn

• Conditions: Breast Cancer; Fatigue

• Registration Number: NCT00914043
• Lead Sponsor: NSABP Foundation Inc

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.

Study Timeline

• Study First Submitted: 2009-06-03
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-10
• Last Update Posted: 2013-01-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship between RNA gene expression pathways and symptoms of fatigue
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