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Computed Tomographic Colonography in Detecting Colorectal Polyps or Cancer



Computed Tomographic Colonography in Detecting Colorectal Polyps or Cancer

For Condition: Rectal Cancer,Colon Cancer
Status: Recruiting
Sponsor(s): Robert H. Lurie Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Computed tomographic colonography may be a less invasive diagnostic procedure than colonoscopy for detecting colorectalpolyps or colorectal cancer. PURPOSE: Diagnostic trial to study the effectiveness of computed tomographic colonography in detecting colorectal polyps or cancer.
Details: OBJECTIVES: - Determine the optimal computed tomographic colonography (CTC) regimen for the detection of colorectal polyps or cancer. - Determine the sensitivity, specificity, and positive and negative predictive values of CTC. - Compare the strengths and weaknesses of CTC vs colonoscopy. OUTLINE: Patients undergo computed tomographic colonography (CTC) followed by standard colonoscopy. CTC and colonoscopy are performed on the same day, whenever possible or within 1 week. Patients who do not tolerate colonoscopy undergo barium enema study. A comparison is made between the findings from CTC and colonoscopy (or barium enema study, if necessary). PROJECTED ACCRUAL: Approximately 235 patients will be accrued for this study.
Eligibility:
Study Type:
  Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Patients who are undergoing work up for suspected colorectal polyp or neoplasm and who are scheduled to undergo colonoscopy for any of the following indications: - Occult bleeding - Iron deficiency anemia - Persistent change in bowel habits - Polyps found during sigmoidoscopy - Strong family history - Prior adenomatous polyps - No toxic colitis, acute colitis, diverticulitis, peritonitis, bowel obstruction, or inflammatory bowel disease - No active rectal bleeding with or without hemodynamic instability - Patients must have undergone standard barium enema or colonoscopy bowel preparation prior to study - Colon must be thoroughly cleaned or have minimal amount of stool PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Cardiovascular: - No recent myocardial infarction Pulmonary: - No recent pulmonary embolus Other: - No inability to tolerate sedation - No adverse reaction to anxiolytics PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - See Disease Characteristics
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
FrankMiller,  Study Chair,  Robert H. Lurie Cancer Center

Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago,  Illinois,  60611
United States
Recruiting Colin  Howden 312-695-4018


Additional Information:
Study ID Numbers:
  CDR0000067727;  NU-9915,NCI-G00-1736
Study Start Date: 
Record last reviewed: June 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005789

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