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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Swedish Association of Local Authorities and Regions
Information provided by (Responsible Party):
Rolf Hultcrantz, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT02078804
First received: February 11, 2014
Last updated: December 21, 2016
Last verified: November 2016
  Purpose

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. Twenty- thousand 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 120 000 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 three 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 50% in the colonoscopy arm and 60% 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.


Condition Intervention
Colorectal Cancer
Procedure: Colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: SCREESCO - Screening of Swedish Colons

Resource links provided by NLM:


Further study details as provided by Uppsala University Hospital:

Primary Outcome Measures:
  • Mortality from colorectal cancer in the Swedish population. [ Time Frame: 15 years follow-up ]

Secondary Outcome Measures:
  • Incidence of colorectal cancer in the Swedish population. [ Time Frame: 15 years follow-up ]
  • To study compliance with the screening program (read study) and what factors are of importance for the adherence rate. [ Time Frame: 1-5 years ]
  • To study health economy and costs for colorectal cancer screening. [ Time Frame: 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. [ Time Frame: 1-5 years ]
  • To study quality control aspects and side effects of screening with colonoscopy. [ Time Frame: 1-5 years ]
  • To study pathology by means of quality registries and digital pathology. [ Time Frame: 1-5 years ]
  • To study surveillance strategies for adenomas found at colonoscopy. [ Time Frame: 1-20 years ]
  • To study associations of DNA in blood with findings at colonoscopy. [ Time Frame: 1-20 years ]
  • To study the flora of fecal bacteria among participants and outcome of FIT and colonoscopy. [ Time Frame: 1-5 years ]

Estimated Enrollment: 200000
Study Start Date: March 2014
Estimated Study Completion Date: December 2034
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Colonoscopy
20 000 subjects will be invited to an once-only colonoscopy.
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.
Experimental: FIT for occult blood
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
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.
No Intervention: Controls
120 000 matched persons will be identified in the Swedish Register of the total population and will be used as controls.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   59 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  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 ClinicalTrials.gov identifier: NCT02078804

Sponsors and Collaborators
Uppsala University Hospital
Swedish Association of Local Authorities and Regions
Investigators
Principal Investigator: Rolf Hultcrantz, Professor Karolinska Institutet, Stockholm, Sweden
  More Information

Publications:
Cancer register: http://www.socialstyrelsen.se/register/halsodataregister/cancerregistret/inenglish: National Board of Health and Welfare; [cited 2014 February].
Armitage N. Screening for cancer. In: Morris D, Kearsley, J, Williams, C, editor. Cancer: a comprehensive clnical guide. pp 9-20. U.K.: Taylor and Francis Ltd 1997.
Register of the total population: https://http://www.skatteverket.se/download/18.2b543913a42158acf80003761/1386594730871/Allm%C3%A4nBeskrivning.pdf: Swedish tax agency; [cited 2014 February].
Patient register: http://www.socialstyrelsen.se/register/halsodataregister/patientregistret/inenglish: National Board of Health and Welfare; [cited 2014 February].
Causes of Death register: http://www.socialstyrelsen.se/register/dodsorsaksregistret: National Board of Health and Welfare; [cited 2014 February].

Responsible Party: Rolf Hultcrantz, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02078804     History of Changes
Other Study ID Numbers: 2012/2058- 31/3
Study First Received: February 11, 2014
Last Updated: December 21, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Uppsala University Hospital:
Colorectal cancer
Mortality
Incidence
Screening
Health-economy

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 May 23, 2017