ACRIN6664The National CT Colonography Trial: Multicenter Assessment of Accuracy for Detection of Large Adenomas and Cancers in a Healthy Screening Population
CT Colonography
Colonic Diseases+8
+ Digestive System Diseases
+ Digestive System Neoplasms
Screening Study
Summary
Study start date: February 1, 2005
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Compare the sensitivity of computed tomographic colonography (CTC) vs colonoscopy for detecting significantly large lesions (≥ 10 mm in diameter) in asymptomatic participants, in terms of specificity, area under the ROC curve, and predictive values for detecting clinically significant colorectal neoplasia. Secondary * Determine the interobserver variation in accuracy of interpreting CTC examinations of these participants, including any benefits of a primary 3-dimensional read and/or independent second interpretations. * Determine the effects of different colon preparations on the accuracy of CTC in these participants. * Compare participant acceptance and willingness to have a repeat examination by CTC vs colonoscopy. * Determine the accuracy of CTC in detecting flat lesions in the colon of these participants. OUTLINE: This is a multicenter study. Participants receive an oral laxative, oral bisacodyl, and three doses of oral barium sulphate 24 hours before imaging. After cathartic cleansing, participants undergo computed tomographic colonography followed by colonoscopy. Participants are followed up for approximately 4 weeks. PROJECTED ACCRUAL: A total of 2,607 participants will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.2600 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Screening Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
1. Inclusion Criteria * Male or female outpatients * Aged 50 years or older * Scheduled for screening colonoscopy * Participant's signed informed consent 2. Exclusion Criteria * Symptoms of disease of the lower gastrointestinal tract, including * Melanotic stools or/and hematochezia on more than one occasion in the previous six months * Lower abdominal pain that would normally require a medical evaluation * Inflammatory bowel disease and/or familial polyposis syndrome * Serious medical conditions that would increase the risk associated with colonoscopy or are so severe that screening would have no benefit * Pregnancy * Previous colonoscopy within the past five years * Anemia (hemoglobin less than 10 gm/dl) * Positive fecal occult blood test (FOBT)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 14 locations
Moores UCSD Cancer Center
La Jolla, United StatesJonsson Comprehensive Cancer Center at UCLA
Los Angeles, United StatesVeterans Affairs Medical Center - San Francisco
San Francisco, United States