Computed Tomographic Colonography in Screening Healthy Participants for Colorectal Cancer
This study has been completed.
Sponsor:
American College of Radiology Imaging Network
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00084929
First received: June 10, 2004
Last updated: July 24, 2012
Last verified: December 2006
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Purpose
RATIONALE: New diagnostic procedures such as computed tomographic colonography may improve the ability to detect colorectal cancer and may provide a less invasive method of detection.
PURPOSE: This clinical trial is studying how well computed tomographic colonography works in screening healthy participants for colorectal cancer.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer |
Procedure: comparison of screening methods Procedure: computed tomography colonography Procedure: screening colonoscopy |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Screening |
| Official Title: | National CT Colonography Trial |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Estimated Enrollment: | 2607 |
| Study Start Date: | February 2005 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Compare the sensitivity of computed tomographic colonography (CTC) vs colonoscopy for detecting significantly large lesions (≥ 10 mm in diameter) in asymptomatic participants, in terms of specificity, area under the ROC curve, and predictive values for detecting clinically significant colorectal neoplasia.
Secondary
- Determine the interobserver variation in accuracy of interpreting CTC examinations of these participants, including any benefits of a primary 3-dimensional read and/or independent second interpretations.
- Determine the effects of different colon preparations on the accuracy of CTC in these participants.
- Compare participant acceptance and willingness to have a repeat examination by CTC vs colonoscopy.
- Determine the accuracy of CTC in detecting flat lesions in the colon of these participants.
OUTLINE: This is a multicenter study.
Participants receive an oral laxative, oral bisacodyl, and three doses of oral barium sulphate 24 hours before imaging. After cathartic cleansing, participants undergo computed tomographic colonography followed by colonoscopy.
Participants are followed up for approximately 4 weeks.
PROJECTED ACCRUAL: A total of 2,607 participants will be accrued for this study.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
DISEASE CHARACTERISTICS:
Scheduled for screening colonoscopy
- No colonoscopy within the past 5 years
- No familial polyposis syndrome
PATIENT CHARACTERISTICS:
Age
- 50 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Hemoglobin ≥ 10 g/dL
Hepatic
- Not specified
Renal
- Not specified
Gastrointestinal
No symptoms of disease of the lower gastrointestinal tract, including any of the following:
- Melanotic stools and/or hematochezia more than once in the past 6 months
- Lower abdominal pain requiring medical evaluation
- No inflammatory bowel disease
- Negative fecal occult blood test
Other
- Not pregnant
- Negative pregnancy test
- No serious medical condition that would increase the risk associated with colonoscopy
- No serious medical condition that is so severe that screening would have no benefit
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084929
Locations
| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259-5499 | |
| United States, California | |
| Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Veterans Affairs Medical Center - San Francisco | |
| San Francisco, California, United States, 94121 | |
| United States, Colorado | |
| Invision/Radiology Imaging Associates - Englewood | |
| Englewood, Colorado, United States, 80112 | |
| United States, Connecticut | |
| Yale Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Clinical Radiologists, S.C. at Memorial Medical Center | |
| Springfield, Illinois, United States, 62781 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Mallinckrodt Institute of Radiology at Washington University Medical Center | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Texas | |
| M.D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| United States, Virginia | |
| Virginia Commonwealth University Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
Sponsors and Collaborators
American College of Radiology Imaging Network
Investigators
| Study Chair: | C. Daniel Johnson, MD | Mayo Clinic |
More Information
Additional Information:
Publications:
Siewert B, Gareen I, Vanness D, et al.: ACRIN 6664: patient acceptance and preferance of CT colonography compared to optical colonoscopy for colon cancer screening. [Abstract] J Clin Oncol 27 (Suppl 15): A-4034, 2009.
| ClinicalTrials.gov Identifier: | NCT00084929 History of Changes |
| Other Study ID Numbers: | CDR0000367101, ACRIN-6664 |
| Study First Received: | June 10, 2004 |
| Last Updated: | July 24, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
colon cancer rectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013