The American Cancer Society estimates that in 2004 there were more than 350,000 new cases of breast or colorectal cancers and almost 100,000 deaths related to these cancers. This is a substantial public health problem that remains the focus the National Surgical Adjuvant Breast and Bowel Project (NSABP). For more than 40 years, the NSABP has successfully conducted large-scale, randomized clinical trials in breast and colorectal cancer designed to improve the standard of care, quality of life and survival of persons who develop these diseases. This research proposal requests funding to enable the continued functioning of the Biostatistical Center of the NSABP which provides: 1) data management support for the collection and processing of data from NSABP trials;2) quality assurance programs which ensure that the collected data is of the highest integrity;3) scientific collaboration in the development of the NSABP research agenda and logistical support for the conduct of the research;and 4) statistical leadership and support for the design, monitoring and analysis of trials and correlative studies. In 2002-2003, the NSABP accounted for 64% of the breast cancer patients and 78% of the colorectal cancer patients who entered the NCI Phase III trials that were available for these patients. Other significant accomplishments made in support of the NSABP scientific agenda during the full course of the prior funding period include: 1) opening of accrual for nine new protocols with 21,000 newly-enrolled patients;2) data collection and management for 43,000 patients;3) conducting over 380 site visit audits involving the review of over 5,200 patients charts;4) implementation of web-based data collection procedures;5) initiation of an ongoing effort to analyze microarray data to assess prognostic and predictive gene profiles;and 6) the publication of almost 200 manuscripts, 36 of which deal with methodology. In the proposed project period, funding will be used to sustain our efforts as a data and statistical center in support of the NSABP scientific agenda and to enhance the utilization of newer technologies for data collection, data management and the communication and training of clinical site collaborators with the goal of developing more efficient methodologies to design, conduct and analyze clinical trials.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
3U10CA069651-18S1
Application #
8413497
Study Section
Subcommittee G - Education (NCI)
Program Officer
Mooney, Margaret M
Project Start
1995-04-28
Project End
2014-01-31
Budget Start
2011-02-01
Budget End
2014-01-31
Support Year
18
Fiscal Year
2012
Total Cost
$3,693,377
Indirect Cost
$1,261,712
Name
University of Pittsburgh
Department
Biostatistics & Other Math Sci
Type
Schools of Public Health
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Ribi, Karin; Luo, Weixiu; Bernhard, Jürg et al. (2016) Adjuvant Tamoxifen Plus Ovarian Function Suppression Versus Tamoxifen Alone in Premenopausal Women With Early Breast Cancer: Patient-Reported Outcomes in the Suppression of Ovarian Function Trial. J Clin Oncol 34:1601-10
Regan, Meredith M; Francis, Prudence A; Pagani, Olivia et al. (2016) Absolute Benefit of Adjuvant Endocrine Therapies for Premenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer: TEXT and SOFT Trials. J Clin Oncol 34:2221-31
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Christian, Nicholas J; Ha, Il Do; Jeong, Jong-Hyeon (2016) Hierarchical likelihood inference on clustered competing risks data. Stat Med 35:251-67
Johansson, Harriet; Gray, Kathryn P; Pagani, Olivia et al. (2016) Impact of CYP19A1 and ESR1 variants on early-onset side effects during combined endocrine therapy in the TEXT trial. Breast Cancer Res 18:110
Gavin, Patrick G; Song, Nan; Kim, S Rim et al. (2015) Immune Signature to Predict Trastuzumab Benefit: Potential and Pitfalls. J Clin Oncol 33:3671-2
George Jr, Thomas J; Allegra, Carmen J; Yothers, Greg (2015) Neoadjuvant Rectal (NAR) Score: a New Surrogate Endpoint in Rectal Cancer Clinical Trials. Curr Colorectal Cancer Rep 11:275-280
Bear, Harry D; Tang, Gong; Rastogi, Priya et al. (2015) Neoadjuvant plus adjuvant bevacizumab in early breast cancer (NSABP B-40 [NRG Oncology]): secondary outcomes of a phase 3, randomised controlled trial. Lancet Oncol 16:1037-48
Haller, D G; O'Connell, M J; Cartwright, T H et al. (2015) Impact of age and medical comorbidity on adjuvant treatment outcomes for stage III colon cancer: a pooled analysis of individual patient data from four randomized, controlled trials. Ann Oncol 26:715-24
Regan, Meredith M; Pagani, Olivia; Francis, Prudence A et al. (2015) Predictive value and clinical utility of centrally assessed ER, PgR, and Ki-67 to select adjuvant endocrine therapy for premenopausal women with hormone receptor-positive, HER2-negative early breast cancer: TEXT and SOFT trials. Breast Cancer Res Treat 154:275-86

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