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Extracolonic Findings on Computed Tomography (CT) Colonography (ACRIN 7151)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT01465425
First received: October 31, 2011
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Incidence and Significance of Extracolonic Findings on CT Colonography: Retrospective Analysis of "National CT Colonography Trial" Data

Resource links provided by NLM:


Further study details as provided by American College of Radiology Imaging Network:

Primary Outcome Measures:
  • Rates of Follow Up Imaging, Hospitalization, Intervention [ Time Frame: 6 Months, 15 Months ] [ Designated as safety issue: No ]
    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:
  • Characterize Outcomes [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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.

  • Estimate Relative Risk [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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).

  • Determine Potential Predictors [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 520
Study Start Date: September 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
E3/E4 Case Group
The Case Group will target consenting 141 participants from the cases with indeterminate but potentially significant findings (E3/E4s) other than pulmonary nodules.
Pulmonary Nodules Case Group
The Pulmonary Nodules Case Group will comprise 119 cases with E3/E4 ECFs characterized as pulmonary nodules.
E1 Control Group
The E1 Control Group will be drawn from the 866 E1 ECF cases from ACRIN 6664 to create a cohort of 260 E1 ECF 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.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All participants originally enrolled in the ACRIN 6664 National CT Colonography Trial are eligible for the ACRIN 7151 trial. 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).

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 nodules.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465425

Sponsors and Collaborators
American College of Radiology Imaging Network
Investigators
Principal Investigator: Hanna M. Zafar, MD, MHS University of Pennsylvania
  More Information

Additional Information:
Publications:
Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT01465425     History of Changes
Other Study ID Numbers: ACRIN 7151, A7151
Study First Received: October 31, 2011
Last Updated: January 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by American College of Radiology Imaging Network:
extracolonic findings
ECFs
CT colonography
computed tomography colonography
National CT Colonography Trial
ACRIN 6664

Additional relevant MeSH terms:
Adrenal Gland Neoplasms
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Kidney Neoplasms
Liver Neoplasms
Multiple Pulmonary Nodules
Neoplasms
Neoplasms, Adnexal and Skin Appendage
Pancreatic Neoplasms
Skin Neoplasms
Solitary Pulmonary Nodule
Adrenal Gland Diseases
Aneurysm
Aortic Diseases
Cardiovascular Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Kidney Diseases
Liver Diseases
Lung Diseases
Lung Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014