This proposal responds to RFA-CA-07-505 """"""""The American College of Radiology Imaging Network"""""""" and addresses the needs of ACRIN's Biostatistics and Data Management Center (BDMC). This proposal is submitted in coordination with a proposal from the Headquarters of ACRIN. Should the funding be awarded, the BDMC of ACRIN will continue to be operated jointly by the Center for Statistical Sciences, Brown University and the American College of Radiology. The main responsibility for data collection and management is with the Philadelphia office of the ACR. The overall direction of the BDMC and the main responsibility for study design, monitoring, and data analysis, is with Brown. Key aspects of the BDMC operation will be the following: 1. To provide support and methodologic leadership to ACRIN investigators in the design, development and implementation of network studies. 2. To work with protocol teams on the design and implementation of data collection forms and procedures. 3. To carry out protocol data collection and to develop and maintain a primary database at the Data Management Center and to ensure efficient and accurate access to the database by Biostatistics Center personnel for study monitoring and analysis. 4. To continually monitor and verify the quality of the data, including checks of accuracy, completeness, and timeliness. To implement procedures designed to guarantee the integrity of the database. 5. To continually monitor and verify protocol compliance and to support participating sites in achieving high standards of performance. To provide methodologic expertise for site audits. 6. To design and perform interim and final analyses and to generate relevant reports. To provide methodologic leadership and support in summarizing study findings and preparing manuscripts. 7. To address methodologic issues arising in the design and analysis of ACRIN studies and to carry out research on statistical methods for the evaluation of diagnostic imaging. 8. To work with investigators and research entities requesting access to ACRIN data and to facilitate the maximum, proper use of scientific information from ACRIN studies. To collaborate in the development of common data elements for imaging clinical studies. 9. To operate and further develop a reliable, nimble, and effective organization, with clearly defined roles and objectives, a well articulated set of Standard Operating Procedures and federal regulation compliance concerning data confidentiality and human subject protection. 10. To organize, facilitate and support outcomes and economics research in ACRIN studies.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
3U10CA079778-14S2
Application #
8729714
Study Section
Special Emphasis Panel (ZCA1-SRRB-9 (O1))
Program Officer
Henderson, Lori A
Project Start
1999-03-01
Project End
2013-12-31
Budget Start
2012-01-01
Budget End
2013-12-31
Support Year
14
Fiscal Year
2013
Total Cost
$151,255
Indirect Cost
$47,043
Name
Brown University
Department
Biostatistics & Other Math Sci
Type
Schools of Public Health
DUNS #
001785542
City
Providence
State
RI
Country
United States
Zip Code
02912
McComb, Barbara L; Munden, Reginald F; Duan, Fenghai et al. (2016) Normative reference values of thoracic aortic diameter in American College of Radiology Imaging Network (ACRIN 6654) arm of National Lung Screening Trial. Clin Imaging 40:936-43
Patz Jr, Edward F; Greco, Erin; Gatsonis, Constantine et al. (2016) Lung cancer incidence and mortality in National Lung Screening Trial participants who underwent low-dose CT prevalence screening: a retrospective cohort analysis of a randomised, multicentre, diagnostic screening trial. Lancet Oncol 17:590-9
Hylton, Nola M; Gatsonis, Constantine A; Rosen, Mark A et al. (2016) Neoadjuvant Chemotherapy for Breast Cancer: Functional Tumor Volume by MR Imaging Predicts Recurrence-free Survival-Results from the ACRIN 6657/CALGB 150007 I-SPY 1 TRIAL. Radiology 279:44-55
Desseroit, Marie-Charlotte; Tixier, Florent; Weber, Wolfgang Andreas et al. (2016) Reliability of PET/CT shape and heterogeneity features in functional and morphological components of Non-Small Cell Lung Cancer tumors: a repeatability analysis in a prospective multi-center cohort. J Nucl Med :
Tromberg, Bruce J; Zhang, Zheng; Leproux, Anaïs et al. (2016) Predicting Responses to Neoadjuvant Chemotherapy in Breast Cancer: ACRIN 6691 Trial of Diffuse Optical Spectroscopic Imaging. Cancer Res 76:5933-5944
Atri, Mostafa; Zhang, Zheng; Dehdashti, Farrokh et al. (2016) Utility of PET-CT to evaluate retroperitoneal lymph node metastasis in advanced cervical cancer: Results of ACRIN6671/GOG0233 trial. Gynecol Oncol 142:413-9
Magbanua, Mark Jesus M; Wolf, Denise M; Yau, Christina et al. (2015) Serial expression analysis of breast tumors during neoadjuvant chemotherapy reveals changes in cell cycle and immune pathways associated with recurrence and response. Breast Cancer Res 17:73
Park, Elyse R; Gareen, Ilana F; Japuntich, Sandra et al. (2015) Primary Care Provider-Delivered Smoking Cessation Interventions and Smoking Cessation Among Participants in the National Lung Screening Trial. JAMA Intern Med 175:1509-16
Weber, Wolfgang A; Gatsonis, Constantine A; Mozley, P David et al. (2015) Repeatability of 18F-FDG PET/CT in Advanced Non-Small Cell Lung Cancer: Prospective Assessment in 2 Multicenter Trials. J Nucl Med 56:1137-43
Pinsky, Paul F; Gierada, David S; Black, William et al. (2015) Performance of Lung-RADS in the National Lung Screening Trial: a retrospective assessment. Ann Intern Med 162:485-91

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