Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00016029
Recruitment Status : Terminated
First Posted : January 27, 2003
Last Update Posted : March 22, 2013
Information provided by (Responsible Party):
Duke University

May 6, 2001
January 27, 2003
March 22, 2013
August 2000
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Complete list of historical versions of study NCT00016029 on Archive Site
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Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer
Prospective Comparison of Air Contrast Barium Enema (ACBE), Computed Tomographic Colonography (Virtual Colonoscopy) and Colonoscopy for Evaluation of the Colon in Patients With Fecal Occult Blood

RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for cancer. New diagnostic procedures such as computed tomographic colonography may provide a less invasive method of identifying patients who have colon cancer.

PURPOSE: Diagnostic and screening trial to compare the effectiveness of barium enema, computed tomographic colonography, and colonoscopy in detecting of colon cancer.


  • Compare the accuracy of air contrast barium enema, computed tomographic colonography (virtual colonoscopy), and colonoscopy for the detection of colonic lesions in patients with factors related to colon cancer.
  • Compare the patient experience during each of these imaging tests.

OUTLINE: This is a multicenter study.

A repeat fecal occult blood test is performed. Patients then undergo an air contrast barium enema (ACBE). At 7-10 days after ACBE, patients undergo a computed tomographic colonography (virtual colonoscopy) followed by a colonoscopy on the same day.

A repeat ACBE may be performed if there is a discrepancy between the initial ACBE and colonoscopy. If the repeat ACBE continues to show an abnormality, patients undergo a second colonoscopy.

Within 24 hours of completion of each test, patients fill out a questionnaire about their experience. At 5-7 days after completion of all tests, patients complete a final questionnaire comparing all 3 tests.

PROJECTED ACCRUAL: A total of 2,133 patients will be accrued for this study within 4 years.

Not Applicable
Primary Purpose: Diagnostic
Colorectal Cancer
  • Other: screening questionnaire administration
  • Procedure: barium enema injection
  • Procedure: computed tomography
  • Procedure: computed tomography colonography
  • Procedure: diagnostic colonoscopy
  • Procedure: screening colonoscopy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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August 2005
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  • One of the following must be present:

    • At least 1 positive fecal occult blood test within the past 6 months
    • Iron deficiency anemia, defined as:

      • Hemoglobin less than 13 g/dL (males)
      • Hemoglobin less than 12 g/dL (females)
      • Ferritin less than 45 g/dL
    • Episode of bright red blood per the rectum
    • Family history of colon cancer or adenoma

      • One first-degree relative diagnosed with colon cancer or adenoma at age 60 or under OR
      • Two first-degree relatives diagnosed with colon cancer or adenoma at any age
  • No active gastrointestinal hemorrhage, including any of the following:

    • Reported or witnessed hematemesis
    • Melenic stools
    • Melenemesis
    • Multiple episodes of hematochezia within the past 2 months



  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • See Disease Characteristics


  • Not specified


  • Not specified


  • No myocardial infarction or cerebrovascular accident within the past 6 weeks


  • No respiratory failure within the past 6 weeks


  • No serious medical disorder (e.g., sepsis) within the past 6 weeks
  • Weight less than 300 pounds
  • Willing and able to undergo endoscopic or radiologic procedures

    • No need for special precautions in performing endoscopic procedures (e.g., antibiotic prophylaxis or complicated anticoagulation reversal)
  • No prisoners
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • No other concurrent clinical trial participation involving drugs, medical devices, and/or biologics
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000068587 ( Other Identifier: NCI )
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Duke University
Duke University
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Study Chair: Don Rockey, MD Duke Cancer Institute
Duke University
September 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP