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Home > "C" Clinical Trials Conditions > Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer  Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer
Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer
For Condition: Colon Cancer,Rectal Cancer
Status: No longer recruiting
Sponsor(s): Duke Comprehensive Cancer Center ,
Synopsis: 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.
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.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DonRockey, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Troy Internal Medicine, P.C.
Troy, Michigan, 48098
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
California Pacific Medical Center - Pacific Campus
San Francisco, California, 94115
United States
Indian River Radiology
Vero Beach, Florida, 32960
United States
California Pacific Medical Center - California Campus
San Francisco, California, 94118-1618
United States
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
University of Texas Medical Branch
Galveston, Texas, 77555
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
United States
Additional Information:
Study ID Numbers: CDR0000068587; DUMC-000866-00-5R,DUMC-CA14326,NCI-V01-1655
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016029
Other Rectal Cancer Studies:
1. Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin
2. Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer
3. Curcumin for the Prevention of Colon Cancer
4. Oxaliplatin Plus Irinotecan in Treating Patients With Metastatic Gastrointestinal Cancer
5. Screening Tests in Detecting Colorectal Cancer
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Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer
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