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Colonoscopy and FIT as Colorectal Cancer Screening Test in the Average Risk Population

NCT02078804 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 278000

Last updated 2025-06-17

No results posted yet for this study

Summary

Colorectal cancer (CRC) is a major cause of death in Sweden. There are approximately 6000 new cases each year in Sweden and the disease specific mortality is more than 40%. There risk is about 1% to develop CRC between 60-70 years of age making 60-year olds a suitable target population for colorectal cancer screening.

The Swedish ministry of health and social affairs proposed a national study on the efficiency of colorectal cancer screening in the Swedish population regarding mortality, but also what screening method to be used. Eighteen participating counties of Sweden now fund the study to be launched in 2014.

From the Register of the total population individuals 59-62 years of age will be randomized and invited by mail to screening. Thirty- thousand five hundred individuals will be invited to primary colonoscopy and 60 000 individuals will be invited to high sensitive FIT (approximately 10% positive) and if positive to a subsequent follow-up colonoscopy. If test negative a second round of FIT will be asked for in two years. In total 183 000 randomized individuals will not be invited to screening, but followed in the Swedish Cancer register and serve as controls. The inclusion period I set to five years (five years with the second round of FIT) generating approximately 5 000 colonoscopies yearly the first three years and 1200 year four and five at a compliance rate of 35% in the colonoscopy arm and 50% in the FIT arm.

Follow-up time is set to 15 years with the primary endpoint disease specific mortality, but also incidence. Secondary outcomes by others to be studied are in short quality assurance variables of colonoscopy, participants and non-participants experiences of the invitation and the screening procedure, health economy measures of the CRC-screening study and when implemented in clinical care.

Conditions

Interventions

PROCEDURE

Colonoscopy

20 000 individuals will be randomised to a primary screening colonoscopy and 60 000 to take a feces test for occult blood (FIT) and if positive (10% of individuals) they will be offered a follow-up colonoscopy.

Sponsors & Collaborators

  • Swedish Association of Local Authorities and Regions

    collaborator OTHER

  • Uppsala University Hospital

    lead OTHER

Principal Investigators

  • Anna Forsberg, MD PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
59 Years
Max Age
62 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-01
Primary Completion
2020-10-31
Completion
2030-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02078804 on ClinicalTrials.gov