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	Treatment or Intervention
Colon Cancer Rectal Cancer	Procedure: barium enema  Procedure: colonoscopic studies  Procedure: computed tomography  Procedure: diagnostic test  Procedure: screening intervention  Procedure: screening questionnaire  Procedure: virtual colonoscopy

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

Don Rockey, MD,  Study Chair,  Duke Comprehensive Cancer Center   

Study ID Numbers:  CDR0000068587; DUMC-000866-00-5R; DUMC-CA14326; NCI-V01-1655
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  May 6, 2001
ClinicalTrials.gov Identifier:  NCT00016029
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08