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

50 Years
Open (Enrolling by invite only)
Solitary Pulmonary Nodules, Multiple Pulmonary Nodules, Renal Neoplasms, Adrenal Gland Neoplasms, Aortic Aneurysm, Abdominal, Liver Neoplasms, Adnexal and Skin Appendage Neoplasms, Lymphadenopathy, Pancreatic Neoplasms

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Trial Information

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.

Inclusion Criteria

No participant sub-populations will be excluded prior to selection (the E1 population will
be matched to the Case Group populations).

Data from the 15 participating sites from the ACRIN 6664 trial provide a study data set of
2531 participants, broken down into a total target study data set of 520 participants.
Participants will be distributed into one of three cohorts as follows:

- The Case Group will target consenting 141 participants from the cases with
indeterminate but potentially significant findings (E3/E4s) other than pulmonary

- The Pulmonary Nodules Case Group will comprise 119 cases with E3/E4 ECFs
characterized as pulmonary nodules.

- The E1 Control Group will be drawn from the 866 E1 ECF cases to create a cohort of
260 E1ECF cases. The Control Group for comparison with the Case Group and the
Pulmonary Nodules Case Group will be selected at the Biostatistics and Data
Management Center (BDMC). The BDMC will match E1 141 controls to the 141 case-group
participants with indeterminate but potentially significant findings (E3/E4s). The
BDMC will also match 119 E1 controls to the 119 E3/E4 pulmonary nodules cases.
Controls will be matched by site, age caliper (5 years), and sex where possible.
Where an appropriate match cannot be obtained, the matching criteria will be relaxed.
If potential participants decline study consent, we will then best-match additional
cases for the appropriate group to maintain target populations. Any additional cases
beyond the initial 520 participants identified for medical record collection will be
matched as feasible.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Outcome Measure:

Rates of Follow Up Imaging, Hospitalization, Intervention

Outcome Description:

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).

Outcome Time Frame:

6 Months, 15 Months

Safety Issue:


Principal Investigator

Hanna M. Zafar, MD, MHS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania


United States: Institutional Review Board

Study ID:

ACRIN 7151



Start Date:

September 2011

Completion Date:

April 2014

Related Keywords:

  • Solitary Pulmonary Nodules
  • Multiple Pulmonary Nodules
  • Renal Neoplasms
  • Adrenal Gland Neoplasms
  • Aortic Aneurysm, Abdominal
  • Liver Neoplasms
  • Adnexal and Skin Appendage Neoplasms
  • Lymphadenopathy
  • Pancreatic Neoplasms
  • extracolonic findings
  • ECFs
  • CT colonography
  • computed tomography colonography
  • National CT Colonography Trial
  • ACRIN 6664
  • Adrenal Gland Neoplasms
  • Aneurysm
  • Aortic Aneurysm
  • Neoplasms
  • Kidney Neoplasms
  • Liver Neoplasms
  • Pancreatic Neoplasms
  • Lung Neoplasms
  • Aortic Aneurysm, Abdominal
  • Neoplasms, Adnexal and Skin Appendage
  • Skin Neoplasms
  • Lymphatic Diseases
  • Multiple Pulmonary Nodules
  • Solitary Pulmonary Nodule