Incidence and Significance of Extracolonic Findings on CT Colonography: Retrospective Analysis of "National CT Colonography Trial" Data
The original ACRIN 6664 National CT Colonography Trial included 15 participating sites and a
total study data set of 2531 participants. The target study data set for the ACRIN 7151
trial is 520 participants, assigned to one of three cohorts: an E3/E4 Case Group (n = 141)
excluding pulmonary nodules, an E3/E4 Pulmonary Nodules Case Group (n = 119), and an E1
Control Group (n = 260) (see Section 8.6). Medical records will be collected by the site
from their institutions and from the primary care provider identified by the participant
during the ACRIN 6664 trial. Initial record collection will comprise the six months
following CTC for all cohorts. Additional medical record collection (from other primary care
providers, specialists, and hospitals, and for extended time periods) may be necessary for
primary endpoint determination. ECFs are categorized according to the original radiology
read of the CTC during the ACRIN 6664 trial.
Observational
Observational Model: Case Control, Time Perspective: Retrospective
Rates of Follow Up Imaging, Hospitalization, Intervention
Estimate the rates of follow-up diagnostic imaging, hospitalization, and interventional procedures commonly associated with ECFs within six months of receiving CTC for all three cohorts (E3/E4, pulmonary nodules, and E1). Compare the rates of medical utilization among participants with indeterminate but potentially significant ECFs (E3/E4s) and participants with pulmonary nodules, to participants with no ECFs (E1s).
6 Months, 15 Months
No
Hanna M. Zafar, MD, MHS
Principal Investigator
University of Pennsylvania
United States: Institutional Review Board
ACRIN 7151
NCT01465425
September 2011
April 2014
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