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

NCT ID: NCT00016029

Last Updated: 2013-03-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 775 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2005-08-31

Brief Summary

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.

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.

Conditions

Colorectal Cancer

Study Design

• Primary Study Purpose: DIAGNOSTIC

Interventions

screening questionnaire administration

Intervention Type: OTHER

barium enema injection

Intervention Type: PROCEDURE

computed tomography

Intervention Type: PROCEDURE

computed tomography colonography

Intervention Type: PROCEDURE

diagnostic colonoscopy

Intervention Type: PROCEDURE

screening colonoscopy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Don Rockey, MD

Role: STUDY_CHAIR

Duke Cancer Institute

Locations

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, United States

California Pacific Medical Center - Pacific Campus

San Francisco, California, United States

California Pacific Medical Center - California Campus

San Francisco, California, United States

Veterans Affairs Medical Center - San Francisco

San Francisco, California, United States

Indian River Radiology

Vero Beach, Florida, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Troy Internal Medicine, P.C.

Troy, Michigan, United States

Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, United States

Veterans Affairs Medical Center - Durham

Durham, North Carolina, United States

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Simmons Cancer Center - Dallas

Dallas, Texas, United States

University of Texas Medical Branch

Galveston, Texas, United States

Massey Cancer Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

DUMC-000866-00-5R

Identifier Type: -

Identifier Source: secondary_id

DUMC-CA14326

Identifier Type: -

Identifier Source: secondary_id

NCI-V01-1655

Identifier Type: -

Identifier Source: secondary_id

CDR0000068587

Identifier Type: OTHER

Identifier Source: secondary_id

0866

Identifier Type: -

Identifier Source: org_study_id