Telemark Polyp Study, a Trial on Colonoscopy Screening (TPS)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Flexible Sigmoidoscopy Screening arm
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Age 55 to 64 years old
- Both male and female
Exclusion criteria:
- Colorectal cancer diagnosed before study entry
Sites / Locations
- Cancer Registry of Norway
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Flexible Sigmoidoscopy Screening arm
Control arm
Arm Description
Intervention by flexible sigmoidoscopy screening
No intervention (no screening)
Outcomes
Primary Outcome Measures
Colorectal cancer mortality
Secondary Outcome Measures
All cause mortality
colorectal cancer incidence
Full Information
NCT ID
NCT01014039
First Posted
November 13, 2009
Last Updated
September 13, 2017
Sponsor
Norwegian Department of Health and Social Affairs
1. Study Identification
Unique Protocol Identification Number
NCT01014039
Brief Title
Telemark Polyp Study, a Trial on Colonoscopy Screening
Acronym
TPS
Official Title
Telemark Polyp Study, a Randomized Trial on Colonoscopy Screening
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 1983 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Norwegian Department of Health and Social Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1433 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flexible Sigmoidoscopy Screening arm
Arm Type
Active Comparator
Arm Description
Intervention by flexible sigmoidoscopy screening
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
No intervention (no screening)
Intervention Type
Procedure
Intervention Name(s)
Flexible Sigmoidoscopy Screening arm
Other Intervention Name(s)
polypectomy
Intervention Description
sigmoidoscopy screening
Primary Outcome Measure Information:
Title
Colorectal cancer mortality
Time Frame
at least 15 years of follow-up
Secondary Outcome Measure Information:
Title
All cause mortality
Time Frame
at least 15 years of follow-up
Title
colorectal cancer incidence
Time Frame
at least 15 years of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 55 to 64 years old
Both male and female
Exclusion criteria:
- Colorectal cancer diagnosed before study entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geir Hoff, MD
Organizational Affiliation
Sykehuset Telemark
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Registry of Norway
City
Oslo
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Telemark Polyp Study, a Trial on Colonoscopy Screening
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