Computed Tomographic Colonography in Screening Healthy Participants for Colorectal Cancer - Full Text View

Sponsors and Collaborators:	American College of Radiology Imaging Network National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00084929

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

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening, Open Label
Official Title:	National CT Colonography Trial

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	2607
Study Start Date:	February 2005

Detailed Description:

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 oral barium sulphate 24 hours before imaging. Participants then undergo computed tomographic colonography followed by colonoscopy.

Participants are followed at 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
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
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
Clinical Radiologists, S.C. at Memorial Medical Center
Springfield, Illinois, United States, 62781
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
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

National Cancer Institute (NCI)

Investigators

Study Chair:

C. Daniel Johnson, MD

Mayo Clinic

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Johnson CD, Chen MH, Toledano AY, Heiken JP, Dachman A, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley K, Iyer RB, Hara AK, Halvorsen RA Jr, Casola G, Yee J, Herman BA, Burgart LJ, Limburg PJ. Accuracy of CT colonography for detection of large adenomas and cancers. N Engl J Med. 2008 Sep 18;359(12):1207-17.

Study ID Numbers:	CDR0000367101, ACRIN-6664
Study First Received:	June 10, 2004
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00084929
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

colon cancer
rectal cancer

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Healthy
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Rectal neoplasm
Digestive System Diseases
Gastrointestinal Neoplasms
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009