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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01014039
First Posted: November 16, 2009
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Geir Hoff, Norwegian Department of Health and Social Affairs
  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
Colorectal Cancer Procedure: Flexible Sigmoidoscopy Screening arm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Geir Hoff, 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 ]

Enrollment: 1433
Study Start Date: March 1983
Study Completion Date: January 2017
Primary Completion Date: January 2017 (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.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion criteria:

- Colorectal cancer diagnosed before study entry

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Geir Hoff, Professor, Norwegian Department of Health and Social Affairs
ClinicalTrials.gov Identifier: NCT01014039     History of Changes
Other Study ID Numbers: TPS
First Submitted: November 13, 2009
First Posted: November 16, 2009
Last Update Posted: September 14, 2017
Last Verified: September 2017

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