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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
  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
Other: screening questionnaire administration
Procedure: barium enema injection
Procedure: computed tomography
Procedure: computed tomography colonography
Procedure: diagnostic colonoscopy
Procedure: screening colonoscopy

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Enrollment: 775
Study Start Date: August 2000
Study Completion Date: August 2005
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
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
California Pacific Medical Center - Pacific Campus
San Francisco, California, United States, 94115
California Pacific Medical Center - California Campus
San Francisco, California, United States, 94118-1618
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 Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00016029     History of Changes
Other Study ID Numbers: 0866, DUMC-000866-00-5R, DUMC-CA14326, NCI-V01-1655, CDR0000068587
Study First Received: May 6, 2001
Last Updated: March 20, 2013
Health Authority: United States: Federal Government
Unites States: Institutional Review Board

Keywords provided by Duke University:
colon cancer
rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 24, 2014