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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Geir Hoff, Norwegian Department of Health and Social Affairs Identifier:
First received: November 13, 2009
Last updated: April 28, 2015
Last verified: April 2015

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
Colorectal Cancer
Procedure: Flexible Sigmoidoscopy Screening arm

Study Type: Interventional
Study Design: Allocation: Randomized
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 mortality [ Time Frame: at least 15 years of follow-up ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: at least 15 years of follow-up ]
  • colorectal cancer incidence [ Time Frame: at least 15 years of follow-up ]

Estimated Enrollment: 1600
Study Start Date: March 1983
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Flexible Sigmoidoscopy Screening arm
Intervention by flexible sigmoidoscopy screening
Procedure: Flexible Sigmoidoscopy Screening arm
sigmoidoscopy screening
Other Name: polypectomy
No Intervention: Control arm
No intervention (no screening)

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.

Ages Eligible for Study:   55 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion criteria:

- Colorectal cancer diagnosed before study entry

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01014039

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

Responsible Party: Geir Hoff, Professor, Norwegian Department of Health and Social Affairs Identifier: NCT01014039     History of Changes
Other Study ID Numbers: TPS
Study First Received: November 13, 2009
Last Updated: April 28, 2015

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases processed this record on March 24, 2017