Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: New diagnostic procedures such as computed tomographic colonography may improve the ability to detect colorectal cancer and may provide a less invasive method of detection.

PURPOSE: This clinical trial is studying how well computed tomographic colonography works in screening healthy participants for colorectal cancer.

Further Study Information

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Scheduled for screening colonoscopy

• No colonoscopy within the past 5 years

• No familial polyposis syndrome

PATIENT CHARACTERISTICS:

Age

• 50 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Hemoglobin ≥ 10 g/dL

Hepatic

• Not specified

Renal

• Not specified

Gastrointestinal

• No symptoms of disease of the lower gastrointestinal tract, including any of the following:

• Melanotic stools and/or hematochezia more than once in the past 6 months

• Lower abdominal pain requiring medical evaluation

• No inflammatory bowel disease

• Negative fecal occult blood test

Other

• Not pregnant

• Negative pregnancy test

• No serious medical condition that would increase the risk associated with colonoscopy

• No serious medical condition that is so severe that screening would have no benefit

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Trial Contact Information

Trial Lead Organizations/Sponsors

American College of Radiology Imaging Network

C. Daniel Johnson

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00084929
Information obtained from ClinicalTrials.gov on December 03, 2012

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