Telemark Polyp Study, a Trial on Colonoscopy Screening (TPS)

September 13, 2017 updated by: Geir Hoff, Norwegian Department of Health and Social Affairs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1433

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Cancer Registry of Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 55 to 64 years old
  • Both male and female

Exclusion criteria:

- Colorectal cancer diagnosed before study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Flexible Sigmoidoscopy Screening arm
Intervention by flexible sigmoidoscopy screening
Procedure: Flexible Sigmoidoscopy Screening arm
sigmoidoscopy screening
Other Names:
  • polypectomy
No Intervention: Control arm
No intervention (no screening)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Colorectal cancer mortality
Time Frame: at least 15 years of follow-up
at least 15 years of follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: at least 15 years of follow-up
at least 15 years of follow-up
colorectal cancer incidence
Time Frame: at least 15 years of follow-up
at least 15 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian Department of Health and Social Affairs

Investigators

  • Study Chair: Geir Hoff, MD, Sykehuset Telemark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1983

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

November 13, 2009

First Submitted That Met QC Criteria

November 13, 2009

First Posted (Estimate)

November 16, 2009

Study Record Updates

Last Update Posted (Actual)

September 14, 2017

Last Update Submitted That Met QC Criteria

September 13, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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