Colorectal CancerNCT00016029
Comparison of Barium Enema, Computed Tomographic Colonography, and Colonoscopy in Detecting Colon Cancer
A study testing screening questionnaire administration, barium enema injection and computed tomography in people with Colorectal Cancer, run by Duke University at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- screening questionnaire administration, barium enema injection and computed tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 775 participants
- Where
- 14 sitesUnited States
- Study dates
- Aug 2000to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
University of Texas Medical Branch
Galveston, Texas, 77555
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
Massey Cancer Center
Richmond, Virginia, 23298-0037
California Pacific Medical Center - Pacific Campus
San Francisco, California, 94115
California Pacific Medical Center - California Campus
San Francisco, California, 94118-1618
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
Troy Internal Medicine, P.C.
Troy, Michigan, 48098
Indian River Radiology
Vero Beach, Florida, 32960
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- screening questionnaire administration, barium enema injection, computed tomography, computed tomography colonography, diagnostic colonoscopy
- Keywords
- colon cancer, rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screening questionnaire administrationOther
barium enema injectionProcedure or surgery
computed tomographyProcedure or surgery
computed tomography colonographyProcedure or surgery
diagnostic colonoscopyProcedure or surgery
screening colonoscopyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 2000
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Enrolment
- 775 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Don Rockey, MD, Study chair, Duke Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016029
- Sponsor's protocol ID
- 0866
- Other IDs
- DUMC-000866-00-5R, DUMC-CA14326, NCI-V01-1655, CDR0000068587
- Status last verified
- Sep 2003
- First submitted
- 6 May 2001
- Last updated
- 22 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00016029
- Acronym / sponsor ID
- 0866
- Conditions
- Colorectal Cancer
- Keywords
- colon cancer, rectal cancer
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 775 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2000
- Study completion
- Aug 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screening questionnaire administration | Other | – |
| barium enema injection | Procedure or surgery | – |
| computed tomography | Procedure or surgery | – |
| computed tomography colonography | Procedure or surgery | – |
| diagnostic colonoscopy | Procedure or surgery | – |
| screening colonoscopy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Don Rockey, MD study chair
Duke Cancer Institute
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing screening questionnaire administration, barium enema injection and computed tomography in people with Colorectal Cancer, run by Duke University at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2013.