) This application responds to the need for a Data and Statistics Center operations for the Multi-Institutional Consortium for Clinical Evaluation of Magnetic Resonance Imaging in Breast Cancer, announced in RFA CA96-012. The proposed center will be based at the Center for Statistical Sciences, Brown University in Philadelphia, PA. Data collection and management will be carried out by the DMC of ACR. Data will be transferred at regular intervals to the Statistics Center at Brown where study monitoring and interim and final analyses will be performed. The key aspects of the operation of the Data and Statistics Center are described in the following specific aims: 1) To provide support and methodological leadership to Consortium investigators in the design, development and implementation of the new protocol; 2) To work with Consortium investigators in the design, development and implementation of data collection forms and procedures. To carry out appropriate pilot testing of protocol implementation and data collection procedures; 3) To carry out the data collection and to develop and maintain a primary study database at the Data Center. To implement an efficient and accurate mechanism for data transfer to the Statistics Center and to develop a database at the Statistics Center for purposes of study monitoring and data analysis; 4) To continually monitor and verify the quality of imaging studies and the compliance to the common protocol. To develop and implement a process for performing site audits and to generate timely audit reports; 5) To continually monitor and verify the quality of the data, including checks of accuracy, completeness and timeliness; 6) To address methodological issues arising in the design and analysis of this multi-center study; 7) To design and perform interim and final analyses of the data and to generate relevant reports; 8) To provide methodological leadership and support in summarizing and interpreting study findings and in the preparation of abstracts and manuscripts. This application for a Data and Statistics Center was planned and submitted in coordination with the application for Headquarters submitted by Dr. Mitchell Schnall, from the University of Pennsylvania.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01CA074696-03
Application #
2896014
Study Section
Special Emphasis Panel (ZCA1-RLB-Y (J2))
Program Officer
Torres-Anjel, Manuel J
Project Start
1997-09-05
Project End
2001-06-30
Budget Start
1999-07-01
Budget End
2000-06-30
Support Year
3
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Brown University
Department
Type
Schools of Medicine
DUNS #
001785542
City
Providence
State
RI
Country
United States
Zip Code
02912
Lehman, Constance D; Isaacs, Claudine; Schnall, Mitchell D et al. (2007) Cancer yield of mammography, MR, and US in high-risk women: prospective multi-institution breast cancer screening study. Radiology 244:381-8
Schnall, Mitchell D; Blume, Jeffrey; Bluemke, David A et al. (2006) Diagnostic architectural and dynamic features at breast MR imaging: multicenter study. Radiology 238:42-53
Lehman, Constance D; Blume, Jeffrey D; Thickman, David et al. (2005) Added cancer yield of MRI in screening the contralateral breast of women recently diagnosed with breast cancer: results from the International Breast Magnetic Resonance Consortium (IBMC) trial. J Surg Oncol 92:9-15; discussion 15-6
Schnall, Mitchell D; Blume, Jeffery; Bluemke, David A et al. (2005) MRI detection of distinct incidental cancer in women with primary breast cancer studied in IBMC 6883. J Surg Oncol 92:32-8
Lehman, Constance D; Blume, Jeffrey D; Weatherall, Paul et al. (2005) Screening women at high risk for breast cancer with mammography and magnetic resonance imaging. Cancer 103:1898-905
Bluemke, David A; Gatsonis, Constantine A; Chen, Mei Hsiu et al. (2004) Magnetic resonance imaging of the breast prior to biopsy. JAMA 292:2735-42
Dukic, V; Gatsonis, C (2003) Meta-analysis of diagnostic test accuracy assessment studies with varying number of thresholds. Biometrics 59:936-46