ACRIN PROTOCOL 7151 Minimize

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

Protocol Documents

Protocol-ACRIN 7151, Amendment 1 with Administrative Update, v4.3.12 [PDF]

Summary of Changes, Amendment 1 with Administrative Update [PDF]

Informed Consent-ACRIN 7151 [DOC]

Authorization to Release/Disclose Medical Records Template [DOC]

ACRIN 7151: Medical Record Procurement Guidelines, v11.2.12 [PDF]

ACRIN 7151 ECF'S MR MOP vNov12 LettersProgressOnly.doc

Training Power Point Slide

Principal Investigator:  Hanna M. Zafar, MD, MHS

Status:  Open

Main Objectives: 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 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
computed tomography colonography (CTC) in colorectal cancer screening and
can potentially be used to develop guidelines for the reporting and management
of ECFs.

Participants: Participants in the ACRIN 7151 trial will be selected from among the
study data set of 2531 participants from the ACRIN 6664 National CT Colonography
. ACRIN 7151 will include participants both with and without ECFs as reported
in ACRIN 6664. Depending on site-specific IRB guidelines, participants may be
contacted to provide consent for medical record abstraction and authorization
for medical record release related to care for ECFs.

Study Design Summary: 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). 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. Data will be collected via professional abstraction
of participant medical records to determine the incidence of diagnostic imaging,
related hospitalizations (e.g., thorascopy), and interventional procedures (e.g.
percutaneous biopsy, open surgery, hospitalizations) that may be associated
with ECFs from CTC.