Know Cancer

or
forgot password

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

Thank you

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 CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Simmons Cancer Center - DallasDallas, Texas  75235-9154
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
University of Texas Medical BranchGalveston, Texas  77555-1329
Massey Cancer CenterRichmond, Virginia  23298-0037
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
California Pacific Medical Center - California CampusSan Francisco, California  94118
California Pacific Medical Center - Pacific CampusSan Francisco, California  94115
Indian River RadiologyVero Beach, Florida  32960
Troy Internal Medicine, P.C.Troy, Michigan  48098