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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Norwegian Department of Health and Social Affairs.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Norwegian Department of Health and Social Affairs
ClinicalTrials.gov Identifier:
NCT01014039
First received: November 13, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Procedure: endoscopy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Telemark Polyp Study, a Randomized Trial on Colonoscopy Screening

Resource links provided by NLM:


Further study details as provided by Norwegian Department of Health and Social Affairs:

Primary Outcome Measures:
  • Colorectal cancer incidence [ Time Frame: at least 10 years of follow-up ] [ Designated as safety issue: No ]
  • Colorectal cancer mortality [ Time Frame: at least 10 years of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: at least 10 years of follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 1600
Study Start Date: March 1983
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Screening
endoscopy
Procedure: endoscopy
sigmoidoscopy/colonoscopy screening
Other Name: polypectomy
No Intervention: Control

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.

  Eligibility

Ages Eligible for Study:   55 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 55 to 64 years old
  • Both male and female
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01014039

Locations
Norway
Cancer Registry of Norway
Oslo, Norway
Sponsors and Collaborators
Norwegian Department of Health and Social Affairs
Investigators
Study Chair: Geir Hoff, MD Sykehuset Telemark
  More Information

No publications provided

Responsible Party: Geir Hoff, The Cancer Registry of Norway
ClinicalTrials.gov Identifier: NCT01014039     History of Changes
Other Study ID Numbers: TPS
Study First Received: November 13, 2009
Last Updated: November 13, 2009
Health Authority: Norway: Ministry of Health and Care Services

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 28, 2014