Colorectal CancerTPSNCT01014039
Telemark Polyp Study, a Trial on Colonoscopy Screening
A study testing Flexible Sigmoidoscopy Screening arm in people with Colorectal Cancer, run by Norwegian Department of Health and Social Affairs at 1 site in Norway.
Trial summary
Colonoscopy screening to reduce mortality and incidence of colorectal cancer (CRC) has been implemented in many western countries. The estimated effect is based on case-control and observational studies. There are no randomized trials quantifying the effect of colonoscopy screening on CRC incidence and mortality. Read more about this study
- Who is it for?
- Ages 55 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Flexible Sigmoidoscopy Screening arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,433 participants
- Where
- 1 siteNorway
- Study dates
- Mar 1983to Jan 2017
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 55 to 64 years old
- Both male and female
Who cannot join
- Colorectal cancer diagnosed before study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telemark Polyp Study, a Randomized Trial on Colonoscopy Screening
Colonoscopy screening to reduce mortality and incidence of colorectal cancer (CRC) has been implemented in many western countries. The estimated effect is based on case-control and observational studies. There are no randomized trials quantifying the effect of colonoscopy screening on CRC incidence and mortality.
The present study investigates the effect of a population-based once-only colonoscopy screening with polypectomy on the incidence of CRC in an average risk population.
In 1983, 900 individuals 55 to 64 years of age were randomly drawn from the population registry of Telemark county, Norway. 400 of these were invited to a flexible sigmoidoscopy screening examination, and 400 individuals were not offered any screening. In 1996, the remainder, both cohorts from 1983 were invited to a colonoscopy screening examination. A new age and sex matched control group, not being offered screening, was randomly drawn from the same registry. Both groups are to be followed with regard to CRC incidence, CRC mortality and all-cause mortality through national Norwegian registries.
Read the detailed description
This as a randomized study of once-only colonoscopy screening (n=685) vs/no screening(care as usual)(n=684). Men and women at 63-72 years of age are recruited from the population registry. The intervention group is invited for screening after a bowel cleansing regimen at home. Follow-up is restricted to trace events (colorectal cancer incidence and deaths) through national registries.
- Conditions
- Colorectal Cancer
- Being tested
- Flexible Sigmoidoscopy Screening arm
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible Sigmoidoscopy Screening armProcedure or surgery
Also called polypectomy
sigmoidoscopy screening
| Study group | Role | What they receive |
|---|---|---|
| Flexible Sigmoidoscopy Screening arm | Active comparator | Intervention by flexible sigmoidoscopy screening Receives: Procedure: Flexible Sigmoidoscopy Screening arm |
| Control arm | No intervention | No intervention (no screening) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer mortality
Measured: at least 15 years of follow-up
Secondary outcomes (2)
All cause mortality
Measured: at least 15 years of follow-up
colorectal cancer incidence
Measured: at least 15 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2009 (estimated)
- Study startMar 1983
- Primary completionJan 2017
- Study completionJan 2017
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
- 1,433 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Department of Health and Social Affairs
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Geir Hoff, Norwegian Department of Health and Social Affairs
- Investigators
- Geir Hoff, MD, Study chair, Sykehuset Telemark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014039
- Sponsor's protocol ID
- TPS
- Acronym
- TPS
- Status last verified
- Sep 2017
- First submitted
- 13 Nov 2009
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemark Polyp Study, a Randomized Trial on Colonoscopy Screening
- ClinicalTrials.gov ID
- NCT01014039
- Acronym / sponsor ID
- TPS / TPS
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,433 participants (actual)
- Lead sponsor
- Norwegian Department of Health and Social AffairsOther government
- Study start
- Mar 1983
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 16 Nov 2009 (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.
Colonoscopy screening to reduce mortality and incidence of colorectal cancer (CRC) has been implemented in many western countries. The estimated effect is based on case-control and observational studies. There are no randomized trials quantifying the effect of colonoscopy screening on CRC incidence and mortality.
The present study investigates the effect of a population-based once-only colonoscopy screening with polypectomy on the incidence of CRC in an average risk population.
In 1983, 900 individuals 55 to 64 years of age were randomly drawn from the population registry of Telemark county, Norway. 400 of these were invited to a flexible sigmoidoscopy screening examination, and 400 individuals were not offered any screening. In 1996, the remainder, both cohorts from 1983 were invited to a colonoscopy screening examination. A new age and sex matched control group, not being offered screening, was randomly drawn from the same registry. Both groups are to be followed with regard to CRC incidence, CRC mortality and all-cause mortality through national Norwegian registries.
Detailed description
This as a randomized study of once-only colonoscopy screening (n=685) vs/no screening(care as usual)(n=684). Men and women at 63-72 years of age are recruited from the population registry. The intervention group is invited for screening after a bowel cleansing regimen at home. Follow-up is restricted to trace events (colorectal cancer incidence and deaths) through national registries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexible Sigmoidoscopy Screening arm | Active comparator | Procedure: Flexible Sigmoidoscopy Screening armIntervention by flexible sigmoidoscopy screening |
| Control arm | No intervention | –No intervention (no screening) |
Who may qualify
- Ages
- 55 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 55 to 64 years old
- Both male and female
Key exclusion criteria (1 listed)
- Colorectal cancer diagnosed before study entry
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 |
|---|---|---|
| Flexible Sigmoidoscopy Screening armAlso: polypectomysigmoidoscopy screening | Procedure or surgery | Flexible Sigmoidoscopy Screening arm |
Primary outcome
Colorectal cancer mortality
Time frame: at least 15 years of follow-up
2 secondary outcomes
All cause mortality
Time frame: at least 15 years of follow-up
colorectal cancer incidence
Time frame: at least 15 years of follow-up
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 14 Sep 2017.
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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.
Geir Hoff, MD study chair
Sykehuset Telemark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible Sigmoidoscopy Screening arm in people with Colorectal Cancer, run by Norwegian Department of Health and Social Affairs at 1 site in Norway.
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 2 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 14 Sep 2017. 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 Norway. 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?
Colorectal cancer mortality (time frame: at least 15 years of follow-up). 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 14 Sep 2017.