Colorectal CancerDCBENCT00619814
Is Barium Enema an Adequate Diagnostic Test for Patients With Positive FOBT?
A study testing Double-contrast Barium enema, colonoscopy in people with Colorectal Cancer, run by VA Caribbean Healthcare System.
Trial summary
The research protocol aim is to compare diagnostic tools for the proper evaluation of patient with fecal occult blood test positive (FOBT +), a routine screening test for colorecatl carcinoma. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Double-contrast Barium enema, colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Oct 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asymptomatic patients older than 50 years of age, with at least one positive FOBT
- Without history of colon cancer and/or polyps
- Gross gastrointestinal bleeding or prior colonoscopy or DCBE
- Who were willing to participate in the study
- Were included in the investigation.
Who cannot join
- Patients with poor cardio-respiratory condition
- Coagulation deficiency, use of anticoagulants or other drugs affecting coagulation
- Severe renal or liver disease
- Hospitalized patients and palpable abdominal or rectal mass were excluded from the study.
About this study
The research protocol aim is to compare diagnostic tools for the proper evaluation of patient with fecal occult blood test positive (FOBT +), a routine screening test for colorecatl carcinoma. The purpose of this study is to determine if Double Contrast Barium Enema (DCBE), a specialized radiographic exam of the colon, is a reasonable alternative for the evaluation of patients with positive fecal occult blood as compared to colonoscopy, which is considered the best evaluation method. Colonoscopy involves the direct visualization of the colon using a flexible instrument. This permits the removal of polyps and to obtain biopsies. It involves additional risks, discomfort and costs. In fact the DCBE is the experimental procedure in this protocol.
Additional aims of this study are: to determine the localization, number, size and pathologic characteristics, if applicable, of findings in colonoscopy and/or DCBE and to determine the patient preference between both studies.
This study is limited to those patients 50 years or older who are at average risk for colon cancer and who had a positive fecal occult blood screening test.
- Conditions
- Colorectal Cancer
- Being tested
- Double-contrast Barium enema, colonoscopy
- Keywords
- Colon polyps, Fecal occult blood test, Double contrast barium enema, Colonoscopy
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double-contrast Barium enema, colonoscopyProcedure or surgery
This is a blinded cohort study comparing double contrast barium enema (DCBE) and colonoscopy in detecting polyps and/or cancer in patients with positive FOBT. Initial evaluation consisted of complete clinical history and physical examination. A DCBE and a colonoscopy were performed in all patients. All polyps identified during colonoscopy were removed and classified by histology. Sensitivity and specificity of DCBE for polyp and/or cancer detection was determined. Tolerability and grade of satisfaction with study procedures was assessed.
| Study group | Role | What they receive |
|---|---|---|
| Cohort group | Other | Cohort group of asymptomatic patients 50-80 years old with a positive fecal occult blood test done for colorectal cancer screening. Receives: Procedure: Double-contrast Barium enema, colonoscopy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startSep 2003
- Primary completionOct 2005
- Study completionOct 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.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Caribbean Healthcare System
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619814
- Sponsor's protocol ID
- 00171
- Acronym
- DCBE
- Status last verified
- Feb 2008
- First submitted
- 8 Feb 2008
- Last updated
- 21 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Barium Enema an Adequate Diagnostic Test for Patients With Positive FOBT?
- ClinicalTrials.gov ID
- NCT00619814
- Acronym / sponsor ID
- DCBE / 00171
- Conditions
- Colorectal Cancer
- Keywords
- Colon polyps, Fecal occult blood test, Double contrast barium enema, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- VA Caribbean Healthcare SystemUS federal agency
- Study start
- Sep 2003
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 21 Feb 2008 (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.
The research protocol aim is to compare diagnostic tools for the proper evaluation of patient with fecal occult blood test positive (FOBT +), a routine screening test for colorecatl carcinoma. The purpose of this study is to determine if Double Contrast Barium Enema (DCBE), a specialized radiographic exam of the colon, is a reasonable alternative for the evaluation of patients with positive fecal occult blood as compared to colonoscopy, which is considered the best evaluation method. Colonoscopy involves the direct visualization of the colon using a flexible instrument. This permits the removal of polyps and to obtain biopsies. It involves additional risks, discomfort and costs. In fact the DCBE is the experimental procedure in this protocol.
Additional aims of this study are: to determine the localization, number, size and pathologic characteristics, if applicable, of findings in colonoscopy and/or DCBE and to determine the patient preference between both studies.
This study is limited to those patients 50 years or older who are at average risk for colon cancer and who had a positive fecal occult blood screening test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort group | Other | Procedure: Double-contrast Barium enema, colonoscopyCohort group of asymptomatic patients 50-80 years old with a positive fecal occult blood test done for colorectal cancer screening. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Asymptomatic patients older than 50 years of age, with at least one positive FOBT
- Without history of colon cancer and/or polyps
- Gross gastrointestinal bleeding or prior colonoscopy or DCBE
- Who were willing to participate in the study
- Were included in the investigation.
Key exclusion criteria (4 listed)
- Patients with poor cardio-respiratory condition
- Coagulation deficiency, use of anticoagulants or other drugs affecting coagulation
- Severe renal or liver disease
- Hospitalized patients and palpable abdominal or rectal mass were excluded from the study.
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 |
|---|---|---|
| Double-contrast Barium enema, colonoscopyThis is a blinded cohort study comparing double contrast barium enema (DCBE) and colonoscopy in detecting polyps and/or cancer in patients with positive FOBT. Initial evaluation consisted of complete clinical history and physical examination. A DCBE and a colonoscopy were performed in all patients. All polyps identified during colonoscopy were removed and classified by histology. Sensitivity and specificity of DCBE for polyp and/or cancer detection was determined. Tolerability and grade of satisfaction with study procedures was assessed. | Procedure or surgery | Cohort group |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Double-contrast Barium enema, colonoscopy in people with Colorectal Cancer, run by VA Caribbean Healthcare System.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 21 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 21 Feb 2008.