Extracolonic Findings on Computed Tomography (CT) Colonography

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

• Registration Number: NCT01465425
• Lead Sponsor: American College of Radiology Imaging Network

Brief 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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-31
• Study First Submitted QC: 2011-11-03
• Study First Posted: 2011-11-04
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-11
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rates of Follow Up Imaging, Hospitalization, Intervention	6 Months, 15 Months	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).

Secondary Outcome Measures

Name	Time	Method
Estimate Relative Risk	6 Months	Estimate the relative risk of confirmed clinically significant findings within six months of receiving CTC among participants with indeterminate but potentially significant ECFs (E3/E4s) and participants with pulmonary nodules, compared with participants with no ECFs (E1s).
Characterize Outcomes	6 Months	Categorize the outcome of potentially clinically significant findings detected by CTC into resolved and unresolved, significant and insignificant at six-months post-examination based on medical record abstraction among participants with indeterminate but potentially clinically significant ECFs (E3/E4s) and participants with pulmonary nodules. Estimate the relationship between participant characteristics and clinically significant findings for participants with E3/E4 ECFs and participants with pulmonary nodules.
Determine Potential Predictors	6 Months	Determine potential predictors associated with increased likelihood of receiving follow-up diagnostic imaging, hospitalization, and interventional procedures within six months of receiving CTC among participants with indeterminate but potentially significant ECFs (E3/E4s), including participants with pulmonary nodules.
Estimate Differences in Cost	6 Months	Estimate differences in cost associated with common expected follow-up diagnostic imaging, hospitalizations, and interventional procedures within six months of receiving CTC among participants with indeterminate but potentially significant ECFs (E3/E4s) and participants with pulmonary nodules, compared with participants with no ECFs (E1s).