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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: computed tomography; Procedure: screening colonoscopy; Procedure: diagnostic colonoscopy; Other: screening questionnaire administration; Procedure: barium enema injection; Procedure: computed tomography colonography

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.

• Study Type: Interventional
• Enrollment (Actual): 775
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Study Chair: Don Rockey, MD, Duke Cancer Institute

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2000
• Study Completion (Actual): August 1, 2005

Study Registration Dates

• First Submitted: May 6, 2001
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): March 22, 2013
• Last Update Submitted That Met QC Criteria: March 20, 2013
• Last Verified: September 1, 2003

More Information

Terms related to this study

• Keywords: rectal cancer; colon cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 0866; DUMC-000866-00-5R; DUMC-CA14326; NCI-V01-1655; CDR0000068587 (Other Identifier: NCI)