search
Back to results

Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
screening questionnaire administration
barium enema injection
computed tomography
computed tomography colonography
diagnostic colonoscopy
screening colonoscopy
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring colon cancer, rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rebecca and John Moores UCSD Cancer Center
  • California Pacific Medical Center - Pacific Campus
  • California Pacific Medical Center - California Campus
  • Veterans Affairs Medical Center - San Francisco
  • Indian River Radiology
  • University of Chicago Cancer Research Center
  • Troy Internal Medicine, P.C.
  • Robert Wood Johnson Medical School
  • NYU School of Medicine's Kaplan Comprehensive Cancer Center
  • Veterans Affairs Medical Center - Durham
  • Duke Comprehensive Cancer Center
  • Simmons Cancer Center - Dallas
  • University of Texas Medical Branch
  • Massey Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2001
Last Updated
March 20, 2013
Sponsor
Duke University
search

1. Study Identification

Unique Protocol Identification Number
NCT00016029
Brief Title
Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2003
Overall Recruitment Status
Terminated
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for cancer. New diagnostic procedures such as computed tomographic colonography may provide a less invasive method of identifying patients who have colon cancer. PURPOSE: Diagnostic and screening trial to compare the effectiveness of barium enema, computed tomographic colonography, and colonoscopy in detecting of colon cancer.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colon cancer, rectal cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Enrollment
775 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
screening questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
barium enema injection
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Intervention Type
Procedure
Intervention Name(s)
computed tomography colonography
Intervention Type
Procedure
Intervention Name(s)
diagnostic colonoscopy
Intervention Type
Procedure
Intervention Name(s)
screening colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Don Rockey, MD
Organizational Affiliation
Duke Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Rebecca and John Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
California Pacific Medical Center - Pacific Campus
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
California Pacific Medical Center - California Campus
City
San Francisco
State/Province
California
ZIP/Postal Code
94118-1618
Country
United States
Facility Name
Veterans Affairs Medical Center - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Indian River Radiology
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Troy Internal Medicine, P.C.
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Veterans Affairs Medical Center - Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Simmons Cancer Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9154
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer

We'll reach out to this number within 24 hrs