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

NCT02078804 | Active Not Recruiting DMC

• 1 other identifier: 2012/2058- 31/3
• Study Type: interventional
• Target: 278,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Colorectal Cancer

Keywords

Colorectal cancer; Mortality; Incidence; Screening; Health-economy

Outcome Measures

Primary Outcomes (1)

• Mortality from colorectal cancer in the Swedish population.

  15 years follow-up

Secondary Outcomes (9)

• Incidence of colorectal cancer in the Swedish population.

  15 years follow-up

• To study compliance with the screening program (read study) and what factors are of importance for the adherence rate.

  1-5 years

• To study health economy and costs for colorectal cancer screening.

  1-20 years

• To study the emotional impact of screening on participants and non-participants including eventual change in lifestyle after invitation and/or participation.

  1-5 years

• To study quality control aspects and side effects of screening with colonoscopy.

  1-5 years

Study Arms (3)

Colonoscopy

EXPERIMENTAL

20 000 subjects will be invited to an once-only colonoscopy.

Procedure: Colonoscopy

FIT for occult blood

EXPERIMENTAL

60 000 persons will be invited to take a fecal test for hemoglobin year 1 and year 3. If test-positive, they will be referred to colonoscopy.

Procedure: Colonoscopy

Controls

NO INTERVENTION

120 000 matched persons will be identified in the Swedish Register of the total population and will be used as controls.

Interventions

Colonoscopy PROCEDURE

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.

Colonoscopy; FIT for occult blood

Eligibility Criteria

• Age: 59 Years - 62 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• People 59-62 years old living in Sweden randomized and identified through the Register of the total population.

You may not qualify if:

• Residents of the counties of Stockholm, Gotland and Västernorrland, individuals with diagnosed with colorectal cancer and/or anal cancer, and individuals randomized to be included in the ongoing NordICC-trial.

Sponsors & Collaborators

• Uppsala University Hospital: lead
• Swedish Association of Local Authorities and Regions: collaborator

Related Publications (28)

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MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Anna Forsberg, MD PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: March 5, 2014
• Study Start: March 1, 2014
• Primary Completion: October 31, 2020
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share