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National CT Colonography Trial


N/A
50 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

National CT Colonography Trial


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Screening

Principal Investigator

C. Daniel Johnson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000367101

NCT ID:

NCT00084929

Start Date:

February 2005

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • colon cancer
  • rectal cancer
  • Colorectal Neoplasms

Name

Location
Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic Cancer Center Rochester, Minnesota  55905
University of Chicago Cancer Research Center Chicago, Illinois  60637
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030
Yale Cancer Center New Haven, Connecticut  06520-8028
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Moores UCSD Cancer Center La Jolla, California  92093-0658
Mallinckrodt Institute of Radiology at Washington University Medical Center St. Louis, Missouri  63110
Invision/Radiology Imaging Associates - Englewood Englewood, Colorado  80112
Clinical Radiologists, S.C. at Memorial Medical Center Springfield, Illinois  62781