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| Tracking Information | |||||
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| First Received Date ICMJE | May 6, 2001 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | August 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00016029 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer | ||||
| Official Title ICMJE | 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 | ||||
| Brief 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Diagnostic | ||||
| Condition ICMJE | Colorectal Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00016029 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068587, DUMC-000866-00-5R, DUMC-CA14326, NCI-V01-1655 | ||||
| Study Sponsor ICMJE | Duke University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | September 2003 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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