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: Clinical trial to study the effectiveness of computed tomographic colonography in screening healthy participants for colorectal cancer.

Condition	Treatment or Intervention
Colon Cancer Rectal Cancer	Procedure: colonoscopic studies  Procedure: comparison of screening methods  Procedure: diagnostic test  Procedure: screening intervention  Procedure: virtual colonoscopy

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 oral barium sulphate 24 hours before imaging. Participants then undergo computed tomographic colonography followed by colonoscopy.

Participants are followed at approximately 4 weeks.

PROJECTED ACCRUAL: A total of 2,289 participants (at least 12 per participating center with proven clinically significant colorectal neoplasia) will be accrued for this study within 2.5 years.

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Study chairs or principal investigators

C. Daniel Johnson, MD,  Study Chair,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000367101; ACRIN-6664
Record last reviewed:  May 2004
Record first received:  June 10, 2004
ClinicalTrials.gov Identifier:  NCT00084929
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-20