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| Sponsored by: |
Duke University |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00016029 |
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 |
Procedure: barium enema injection Procedure: computed tomography Procedure: computed tomography colonography Procedure: diagnostic colonoscopy Procedure: screening colonoscopy Procedure: screening questionnaire administration |
| Genetics Home Reference related topics: | Colorectal Cancer |
| MedlinePlus related topics: | CT Scans Cancer Colorectal Cancer |
| Study Type: | Interventional |
| Study Design: | 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 |
| Study Start Date: | August 2000 |
OBJECTIVES:
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:
Iron deficiency anemia, defined as:
Family history of colon cancer or adenoma
No active gastrointestinal hemorrhage, including any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
Willing and able to undergo endoscopic or radiologic procedures
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, California | |||||
| 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 | |||||
| Rebecca and John Moores UCSD Cancer Center | |||||
| La Jolla, California, United States, 92093-0658 | |||||
| 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 | |||||
| Duke University |
| Study Chair: | Don Rockey, MD | Duke University |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068587, DUMC-000866-00-5R, DUMC-CA14326, NCI-V01-1655 |
| First Received: | May 6, 2001 |
| Last Updated: | May 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00016029 |
| Health Authority: | United States: Federal Government |
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