Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer
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Purpose
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 | Intervention |
|---|---|
|
Colorectal Cancer |
Other: screening questionnaire administration Procedure: barium enema injection Procedure: computed tomography Procedure: computed tomography colonography Procedure: diagnostic colonoscopy Procedure: screening colonoscopy |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Diagnostic |
| 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 |
| Enrollment: | 775 |
| Study Start Date: | August 2000 |
| Study Completion Date: | August 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| Rebecca and John Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| California Pacific Medical Center - California Campus | |
| San Francisco, California, United States, 94118-1618 | |
| California Pacific Medical Center - Pacific Campus | |
| San Francisco, California, United States, 94115 | |
| Veterans Affairs Medical Center - San Francisco | |
| San Francisco, California, United States, 94121 | |
| United States, Florida | |
| Indian River Radiology | |
| Vero Beach, Florida, United States, 32960 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Michigan | |
| Troy Internal Medicine, P.C. | |
| Troy, Michigan, United States, 48098 | |
| United States, New Jersey | |
| Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| United States, New York | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Veterans Affairs Medical Center - Durham | |
| Durham, North Carolina, United States, 27705 | |
| United States, Texas | |
| Simmons Cancer Center - Dallas | |
| Dallas, Texas, United States, 75235-9154 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555 | |
| United States, Virginia | |
| Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Study Chair: | Don Rockey, MD | Duke Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00016029 History of Changes |
| Other Study ID Numbers: | 0866, DUMC-000866-00-5R, DUMC-CA14326, NCI-V01-1655, CDR0000068587 |
| Study First Received: | May 6, 2001 |
| Last Updated: | March 20, 2013 |
| Health Authority: | United States: Federal Government Unites States: Institutional Review Board |
Keywords provided by Duke University:
|
colon cancer rectal cancer |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013