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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.
ClinicalTrials.gov Identifier:
First Posted: March 5, 2014
Last Update Posted: December 22, 2016
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.
Swedish Association of Local Authorities and Regions
Information provided by (Responsible Party):
Rolf Hultcrantz, Karolinska Institutet

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: None (Open Label)
Primary Purpose: Screening
Official Title: SCREESCO - Screening of Swedish Colons

Resource links provided by NLM:

Further study details as provided by Rolf Hultcrantz, Karolinska Institutet:

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.

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Information from the National Library of Medicine

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

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
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): NCT02078804

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

Cancer register: http://www.socialstyrelsen.se/register/halsodataregister/cancerregistret/inenglish: National Board of Health and Welfare; [cited 2014 February].
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Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81.
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Thiis-Evensen E, Hoff GS, Sauar J, Langmark F, Majak BM, Vatn MH. Population-based surveillance by colonoscopy: effect on the incidence of colorectal cancer. Telemark Polyp Study I. Scand J Gastroenterol. 1999 Apr;34(4):414-20.
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.
Mandel JS, Bond JH, Church TR, Snover DC, Bradley GM, Schuman LM, Ederer F. Reducing mortality from colorectal cancer by screening for fecal occult blood. Minnesota Colon Cancer Control Study. N Engl J Med. 1993 May 13;328(19):1365-71. Erratum in: N Engl J Med 1993 Aug 26;329(9):672.
Kronborg O, Fenger C, Olsen J, Jørgensen OD, Søndergaard O. Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet. 1996 Nov 30;348(9040):1467-71.
Hardcastle JD, Chamberlain JO, Robinson MH, Moss SM, Amar SS, Balfour TW, James PD, Mangham CM. Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet. 1996 Nov 30;348(9040):1472-7.
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Register of the total population: https://http://www.skatteverket.se/download/18.2b543913a42158acf80003761/1386594730871/Allm%C3%A4nBeskrivning.pdf: Swedish tax agency; [cited 2014 February].
von Karsa L, Patnick J, Segnan N. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition--Executive summary. Endoscopy. 2012 Sep;44 Suppl 3:SE1-8. Epub 2012 Sep 25.
Rembacken B, Hassan C, Riemann JF, Chilton A, Rutter M, Dumonceau JM, Omar M, Ponchon T. Quality in screening colonoscopy: position statement of the European Society of Gastrointestinal Endoscopy (ESGE). Endoscopy. 2012 Oct;44(10):957-68. doi: 10.1055/s-0032-1325686. Epub 2012 Sep 17.
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
First Submitted: February 11, 2014
First Posted: March 5, 2014
Last Update Posted: December 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rolf Hultcrantz, Karolinska Institutet:
Colorectal cancer

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

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