The American Cancer Society estimates that annually there are 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 50 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. Since 1984, when NSABP became a CCOP Research Base, the CCOP investigators have accounted for approximately 30,000 treatment trial patients and more than 33,100 participants have been enrolled in the BCPT and STAR breast cancer prevention trials. The timeliness and quality of data obtained through these programs have been exceptional and have contributed positively to overall NSABP data integrity and have substantially enhanced the base of scientific information regarding the treatment and prevention of cancer. In the proposed project period, funding will be used to sustain our efforts as a data and statistical center in support of the NSABP CCOP treatment, cancer control and prevention scientific agenda. In that capacity, we will continue 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, This research proposal requests funding to enable the continued functioning of the CCOP, MB-CCOP and Prevention components of the NSABP Biostatistical Center which provide: 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.

Public Health Relevance

Breast and Colorectal cancer is a substantial public health problem that is the focus of the National Surgical Adjuvant Breast and Bowel Project (NSABP). The focus of the NSABP is the conduct of large-scale, clinical trials designed to improve the standard of care, quality of life and survival of persons who develop these diseases as well as the conduct of breast and colorectal cancer prevention studies. Our current and planned studies are designed to improve the prevention and treatment of these diseases.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
2U10CA069974-17
Application #
8306364
Study Section
Special Emphasis Panel (ZCA1-SRLB-B (J1))
Program Officer
Mccaskill-Stevens, Worta J
Project Start
1995-09-01
Project End
2015-05-31
Budget Start
2012-08-01
Budget End
2013-05-31
Support Year
17
Fiscal Year
2012
Total Cost
$3,888,511
Indirect Cost
$1,469,667
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
O'Connell, Michael J; Colangelo, Linda H; Beart, Robert W et al. (2014) Capecitabine and oxaliplatin in the preoperative multimodality treatment of rectal cancer: surgical end points from National Surgical Adjuvant Breast and Bowel Project trial R-04. J Clin Oncol 32:1927-34
Ha, Il Do; Lee, Minjung; Oh, Seungyoung et al. (2014) Variable selection in subdistribution hazard frailty models with competing risks data. Stat Med 33:4590-604
Land, Stephanie R; Liu, Qing; Wickerham, D Lawrence et al. (2014) Cigarette smoking, physical activity, and alcohol consumption as predictors of cancer incidence among women at high risk of breast cancer in the NSABP P-1 trial. Cancer Epidemiol Biomarkers Prev 23:823-32
Lee, Minjung; Dignam, James J; Han, Junhee (2014) Multiple imputation methods for nonparametric inference on cumulative incidence with missing cause of failure. Stat Med 33:4605-26
Klepin, Heidi D; Geiger, Ann M; Bandos, Hanna et al. (2014) Cognitive factors associated with adherence to oral antiestrogen therapy: results from the cognition in the study of tamoxifen and raloxifene (Co-STAR) study. Cancer Prev Res (Phila) 7:161-8
Han, Baoguang; Yu, Menggang; Dignam, James J et al. (2014) Bayesian approach for flexible modeling of semicompeting risks data. Stat Med 33:5111-25
Choi, Jiin; Anderson, Stewart J; Richards, Thomas J et al. (2014) Prediction of transplant-free survival in idiopathic pulmonary fibrosis patients using joint models for event times and mixed multivariate longitudinal data. J Appl Stat 41:2192-2205
Schaid, Daniel J; Jenkins, Gregory D; Ingle, James N et al. (2013) Two-phase designs to follow-up genome-wide association signals with DNA resequencing studies. Genet Epidemiol 37:229-38
Siziopikou, Kalliopi P; Anderson, Stewart J; Cobleigh, Melody A et al. (2013) Preliminary results of centralized HER2 testing in ductal carcinoma in situ (DCIS): NSABP B-43. Breast Cancer Res Treat 142:415-21
Swain, Sandra M; Tang, Gong; Geyer Jr, Charles E et al. (2013) Definitive results of a phase III adjuvant trial comparing three chemotherapy regimens in women with operable, node-positive breast cancer: the NSABP B-38 trial. J Clin Oncol 31:3197-204

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