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Prospective Comparison of Air Contrast Barium Enema (ACBE), Computed Tomographic Colonography (Virtual Colonoscopy) and Colonoscopy for Evaluation of the Colon in Patients With Fecal Occult Blood


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

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Trial Information

Prospective Comparison of Air Contrast Barium Enema (ACBE), Computed Tomographic Colonography (Virtual Colonoscopy) and Colonoscopy for Evaluation of the Colon in Patients With Fecal Occult Blood


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Don Rockey, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

0866

NCT ID:

NCT00016029

Start Date:

August 2000

Completion Date:

August 2005

Related Keywords:

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

Name

Location

University of Chicago Cancer Research Center Chicago, Illinois  60637
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
University of Texas Medical Branch Galveston, Texas  77555-1329
Massey Cancer Center Richmond, Virginia  23298-0037
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
California Pacific Medical Center - California Campus San Francisco, California  94118
California Pacific Medical Center - Pacific Campus San Francisco, California  94115
Indian River Radiology Vero Beach, Florida  32960
Troy Internal Medicine, P.C. Troy, Michigan  48098