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

Duke University

Status

Terminated

Conditions

Colorectal Cancer

Treatments

Procedure: barium enema injection

Procedure: screening colonoscopy

Procedure: computed tomography colonography

Procedure: diagnostic colonoscopy

Procedure: computed tomography

Other: screening questionnaire administration

Study type

Interventional

Funder types

Other

Identifiers

NCT00016029

0866

DUMC-000866-00-5R

DUMC-CA14326

CDR0000068587 (Other Identifier)

NCI-V01-1655

Details and patient eligibility

About

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.

Full 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.

Enrollment

775 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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