Telemark Polyp Study, a Trial on Colonoscopy Screening
TPS
Telemark Polyp Study, a Randomized Trial on Colonoscopy Screening
1 other identifier
interventional
1,433
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Mar 1983
Longer than P75 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 1983
CompletedFirst Submitted
Initial submission to the registry
November 13, 2009
CompletedFirst Posted
Study publicly available on registry
November 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedSeptember 14, 2017
September 1, 2017
33.9 years
November 13, 2009
September 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Colorectal cancer mortality
at least 15 years of follow-up
Secondary Outcomes (2)
All cause mortality
at least 15 years of follow-up
colorectal cancer incidence
at least 15 years of follow-up
Study Arms (2)
Flexible Sigmoidoscopy Screening arm
ACTIVE COMPARATORIntervention by flexible sigmoidoscopy screening
Control arm
NO INTERVENTIONNo intervention (no screening)
Interventions
sigmoidoscopy screening
Eligibility Criteria
You may qualify if:
- Age 55 to 64 years old
- Both male and female
You may not qualify if:
- \- Colorectal cancer diagnosed before study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Registry of Norway
Oslo, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Geir Hoff, MD
Sykehuset Telemark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 13, 2009
First Posted
November 16, 2009
Study Start
March 1, 1983
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
September 14, 2017
Record last verified: 2017-09