Colorectal CancerNCT00812942
Participation to Colorectal Cancer Screening With Fecal Occult Blood Test and Colonoscopy
A study testing colonoscopy and faecal test in people with Colorectal Cancer, run by Istituto Superiore di Sanità at 1 site in Italy.
Trial summary
Adherence rate to screening colonoscopy (TC) in the average-risk general population is still unclear. Aim of this study was to compare the uptake of TC screening with that of fecal occult blood (FOBT) in the general population of different Italian areas. Read more about this study
- Who is it for?
- Ages 55 to 64 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- colonoscopy and faecal test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,889 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2003to Nov 2008
- 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 55 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- asymptomatic 55-64 years subjects
Who cannot join
- already studied for colorectal cancer, severe comorbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Participation to Colorectal Cancer Screening With Faecal Occult Blood Test and Colonoscopy: an Italian, Multicenter, Randomized Population Study
Adherence rate to screening colonoscopy (TC) in the average-risk general population is still unclear. Aim of this study was to compare the uptake of TC screening with that of fecal occult blood (FOBT) in the general population of different Italian areas.
Read the detailed description
A nationwide, population-based, multicenter, randomized trial comparing attendance to TC with that to FOBT was performed. Sixty-four general practitioners (GPs), overall including in their lists 9,889 average-risk subjects aged 55-64 years, were randomized between TC and FOBT screening programs. Eligible subjects were mailed a personal invitation letter co-signed by their GP and the coordinator of the area-reference GI centre. Attendance rate and detection rate for advanced neoplasia (colorectal cancer, adenoma >10 mm or with villous histology or high-grade dysplasia) for each arm of the study were assessed.
- Conditions
- Colorectal Cancer
- Being tested
- colonoscopy, faecal test
- Keywords
- average-risk subjects for
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyProcedure or surgery
colonoscopy screening
faecal testProcedure or surgery
faecal occult blood test for screening
| Study group | Role | What they receive |
|---|---|---|
| fobt | Active comparator | faecal occult blood test Receives: Procedure: faecal test |
| colonoscopy | Active comparator | colonoscopy screening Receives: Procedure: colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation to colorectal cancer screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startNov 2003
- Primary completionNov 2005
- Study completionNov 2008
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9,889 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Superiore di Sanità
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812942
- Sponsor's protocol ID
- 1
- Status last verified
- Dec 2008
- First submitted
- 18 Dec 2008
- Last updated
- 22 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participation to Colorectal Cancer Screening With Faecal Occult Blood Test and Colonoscopy: an Italian, Multicenter, Randomized Population Study
- ClinicalTrials.gov ID
- NCT00812942
- Acronym / sponsor ID
- 1
- Conditions
- Colorectal Cancer
- Keywords
- average-risk subjects for
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,889 participants (actual)
- Lead sponsor
- Istituto Superiore di SanitàUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 22 Dec 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.
Adherence rate to screening colonoscopy (TC) in the average-risk general population is still unclear. Aim of this study was to compare the uptake of TC screening with that of fecal occult blood (FOBT) in the general population of different Italian areas.
Detailed description
A nationwide, population-based, multicenter, randomized trial comparing attendance to TC with that to FOBT was performed. Sixty-four general practitioners (GPs), overall including in their lists 9,889 average-risk subjects aged 55-64 years, were randomized between TC and FOBT screening programs. Eligible subjects were mailed a personal invitation letter co-signed by their GP and the coordinator of the area-reference GI centre. Attendance rate and detection rate for advanced neoplasia (colorectal cancer, adenoma >10 mm or with villous histology or high-grade dysplasia) for each arm of the study were assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fobt | Active comparator | Procedure: faecal testfaecal occult blood test |
| colonoscopy | Active comparator | Procedure: colonoscopycolonoscopy screening |
Who may qualify
- Ages
- 55 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- asymptomatic 55-64 years subjects
Key exclusion criteria (1 listed)
- already studied for colorectal cancer, severe comorbidities
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 |
|---|---|---|
| colonoscopycolonoscopy screening | Procedure or surgery | colonoscopy |
| faecal testfaecal occult blood test for screening | Procedure or surgery | fobt |
Primary outcome
Participation to colorectal cancer screening
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 22 Dec 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colonoscopy and faecal test in people with Colorectal Cancer, run by Istituto Superiore di Sanità at 1 site in Italy.
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 1 inclusion and 1 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 22 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 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.
What does the primary outcome measure?
Participation to colorectal cancer screening. It is what the study was designed to measure, not a finding.
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 Dec 2008.