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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00016029
• Other study ID #: 0866
• Secondary ID: DUMC-000866-00-5
• Status: Terminated
• Phase: N/A
• First received: May 6, 2001
• Last updated: March 20, 2013
• Start date: August 2000
• Est. completion date: August 2005

Study information

• Verified date: September 2003
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnites States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 775
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Other:
• screening questionnaire administration

Procedure:
• barium enema injection

• computed tomography

• computed tomography colonography

• diagnostic colonoscopy

• screening colonoscopy

Locations

Country	Name	City	State
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Veterans Affairs Medical Center - Durham	Durham	North Carolina
United States	University of Texas Medical Branch	Galveston	Texas
United States	Rebecca and John Moores UCSD Cancer Center	La Jolla	California
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	Massey Cancer Center	Richmond	Virginia
United States	California Pacific Medical Center - California Campus	San Francisco	California
United States	California Pacific Medical Center - Pacific Campus	San Francisco	California
United States	Veterans Affairs Medical Center - San Francisco	San Francisco	California
United States	Troy Internal Medicine, P.C.	Troy	Michigan
United States	Indian River Radiology	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

External Links

•   Link