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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2013 |
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Main ID: |
NCT00016029 |
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Date of registration:
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06/05/2001 |
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Primary sponsor: |
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Public title:
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Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer
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Scientific title:
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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 |
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Date of first enrolment:
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August 2000 |
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Target sample size:
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775 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00016029 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Diagnostic
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Countries of recruitment
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United States
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Contacts
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Name:
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Don Rockey, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Duke Cancer Institute |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Intervention(s)
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Other: screening questionnaire administration
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Procedure: barium enema injection
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Procedure: computed tomography
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Procedure: computed tomography colonography
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Procedure: diagnostic colonoscopy
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Procedure: screening colonoscopy
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Secondary ID(s)
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0866
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CDR0000068587
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DUMC-000866-00-5R
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DUMC-CA14326
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NCI-V01-1655
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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