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

This study is ongoing, but not recruiting participants.

Sponsored by: Duke University
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00016029
  Purpose

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.


Condition Intervention
Colorectal Cancer
Procedure: barium enema injection
Procedure: computed tomography
Procedure: computed tomography colonography
Procedure: diagnostic colonoscopy
Procedure: screening colonoscopy
Procedure: screening questionnaire administration

Genetics Home Reference related topics:   Colorectal Cancer  

MedlinePlus related topics:   CT Scans   Cancer   Colorectal Cancer  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic
Official Title:   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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   August 2000

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016029

Locations
United States, California
California Pacific Medical Center - California Campus    
      San Francisco, California, United States, 94118-1618
California Pacific Medical Center - Pacific Campus    
      San Francisco, California, United States, 94115
Rebecca and John Moores UCSD Cancer Center    
      La Jolla, California, United States, 92093-0658
Veterans Affairs Medical Center - San Francisco    
      San Francisco, California, United States, 94121
United States, Florida
Indian River Radiology    
      Vero Beach, Florida, United States, 32960
United States, Illinois
University of Chicago Cancer Research Center    
      Chicago, Illinois, United States, 60637-1470
United States, Michigan
Troy Internal Medicine, P.C.    
      Troy, Michigan, United States, 48098
United States, New Jersey
Robert Wood Johnson Medical School    
      New Brunswick, New Jersey, United States, 08903
United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center    
      New York, New York, United States, 10016
United States, North Carolina
Duke Comprehensive Cancer Center    
      Durham, North Carolina, United States, 27710
Veterans Affairs Medical Center - Durham    
      Durham, North Carolina, United States, 27705
United States, Texas
Simmons Cancer Center - Dallas    
      Dallas, Texas, United States, 75235-9154
University of Texas Medical Branch    
      Galveston, Texas, United States, 77555
United States, Virginia
Massey Cancer Center    
      Richmond, Virginia, United States, 23298-0037

Sponsors and Collaborators
Duke University

Investigators
Study Chair:     Don Rockey, MD     Duke University    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068587, DUMC-000866-00-5R, DUMC-CA14326, NCI-V01-1655
First Received:   May 6, 2001
Last Updated:   May 23, 2008
ClinicalTrials.gov Identifier:   NCT00016029
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
colon cancer  
rectal cancer  

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal cancer
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Digestive System Diseases
Neoplasms by Site

ClinicalTrials.gov processed this record on July 03, 2008




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