NCT01465425

Extracolonic Findings on Computed Tomography (CT) Colonography

Incidence and Significance of Extracolonic Findings on CT Colonography: Retrospective Analysis of "National CT Colonography Trial" Data

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 520 (estimated)
• Sponsor: American College of Radiology Imaging Network · Network
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The ACRIN 7151 trial will use medical records abstraction data from participants with extracolonic findings (ECFs) reported from the ACRIN 6664 National CT Colonography Trial to: 1) measure incidence of diagnostic imaging, hospitalization, and interventional procedures associated with ECFs reported on computed tomography colonography (CTC), delineated by type of ECF; 2) determine potential predictors of follow-up diagnostic imaging, hospitalization, and interventional procedures, delineated by type of ECF; and 3) evaluate the clinical/pathologic diagnoses associated with indeterminate but potentially significant ECFs. These data can be used to incorporate ECFs into existing models on the cost-effectiveness of CTC in colorectal cancer screening and can potentially be used to develop guidelines for the reporting and management of ECFs.

Detailed description

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.

Conditions

• Solitary Pulmonary Nodules
• Multiple Pulmonary Nodules
• Renal Neoplasms
• Adrenal Gland Neoplasms
• Aortic Aneurysm, Abdominal
• Liver Neoplasms
• Adnexal and Skin Appendage Neoplasms
• Lymphadenopathy
• Pancreatic Neoplasms

Timeline

• Start date: 2011-09-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2011-11-04
• Last updated: 2018-10-11