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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00016029
First received: May 6, 2001
Last updated: March 20, 2013
Last verified: September 2003

May 6, 2001
March 20, 2013
August 2000
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Complete list of historical versions of study NCT00016029 on ClinicalTrials.gov 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.

OBJECTIVES:

  • 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.

Interventional
Not Provided
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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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
775
August 2005
Not Provided

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

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

Pulmonary:

  • No respiratory failure within the past 6 weeks

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No other concurrent clinical trial participation involving drugs, medical devices, and/or biologics
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00016029
0866, DUMC-000866-00-5R, DUMC-CA14326, NCI-V01-1655, CDR0000068587
Not Provided
Duke University
Duke University
Not Provided
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