NORCCAP: Norwegian Colorectal Cancer Prevention Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Norwegian Cancer Society
Information provided by (Responsible Party):
Norwegian Department of Health and Social Affairs
ClinicalTrials.gov Identifier:
NCT00119912
First received: July 6, 2005
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to see if screening with flexible sigmoidoscopy (a flexible viewing tube) may reduce large bowel cancer and cancer deaths. The researchers also want to see if the addition of screening for occult blood in stools may contribute further to this aim. Additionally, the researchers also want to see to which extent (and in which direction) the study may influence overall endoscopic activity in the general population in the screening area and in areas where controlled screening is not established.


Condition Intervention Phase
Colorectal Cancer
Adenoma
Procedure: Flexible sigmoidoscopy
Procedure: Fecal Occult Blood Test (FOBT) screening
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Norwegian Colorectal Cancer Prevention Trial

Resource links provided by NLM:


Further study details as provided by Norwegian Department of Health and Social Affairs:

Primary Outcome Measures:
  • 1. Evaluate the effect on CRC mortality and morbidity by screen detection of CRC and removal of precursor lesions (polypectomy of adenomatous polyps).First evaluation after 5 years. [ Time Frame: Evaluations in 2007 (published),2012,2017 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1. Determine the prevalence of known types familial CRC in a general population and try to define other groups with intermediate increased risk. Results "in press" 2005. [ Time Frame: Evaluated in 2005 (published) ] [ Designated as safety issue: No ]
  • 2. Clarify possible psychosocial effects of endoscopic screening and how it may influence lifestyle and lifestyle related morbidity and overall mortality. Evaluation in 2005. [ Time Frame: Evaluated in 2005 (published) ] [ Designated as safety issue: Yes ]

Enrollment: 100000
Study Start Date: January 1999
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Randomised from the population registry, age 50-64 years and invited for Flexible Sigmoidoscopy screening. Half of invitees are additionally invited to provide a stool sample for fecal occult blood testing.
Procedure: Flexible sigmoidoscopy Procedure: Fecal Occult Blood Test (FOBT) screening
In addition to Flexible Sigmoidoscopy, half of arm A (randomised 1:1) is invited to provide stool samples for FOBT
No Intervention: B
"No screening group" randomised from population age 50-64 years

Detailed Description:

Although flexible sigmoidoscopy (FS) as a screening tool has a much higher test sensitivity than fecal occult blood tests (FOBT) for colorectal cancer and high-risk adenomas, randomised trials with long-term follow-up are missing. The primary aim is to evaluate the effect on CRC mortality and morbidity by screen detection of CRC and removal of precursor lesions (polypectomy of adenomatous polyps)

Secondary aims:

  1. Evaluation of cost/effectiveness of screening for CRC and significant, benign lesions using flex-sig only compared to flex-sig in combination with faecal tests
  2. To evaluate to which extent (and in which direction) the study may influence overall endoscopic activity in the general population in the screening areas and in areas where controlled screening is not established
  3. Determine the prevalence of known types familial CRC in a general population and try to define other groups with intermediate increased risk
  4. Clarify possible psychosocial effects of endoscopic screening and how it may influence lifestyle and lifestyle related morbidity and overall mortality

Population:

21,000 men and women, aged 50-64 years, living in the city of Oslo or the county of Telemark are drawn by randomisation (approx. 1:5) from the population registry and invited to have a flexible sigmoidoscopy examination. The control group constitutes 79,000 individuals. Those invited for flexible sigmoidoscopy are further randomised (1:1) to bring or not to bring 3 successive stool samples for FOBT on attendance for FS.

Method:

This is a once-only screening concept with bowel cleansing being limited to a 240 ml Sorbitol enema given on attendance. The threshold for work-up colonoscopy is low as a positive screening test is defined as any polyp >9mm, any histologically verified adenoma irrespective of size and a positive FOBT. The screening phase is limited to the period January 1999- January 2002 and the first follow-up results will not be reported until all entries have passed the 5-year mark (i.e. in early 2007).

  Eligibility

Ages Eligible for Study:   50 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women
  • Living in Oslo or Telemark
  • Age 50-64 years

Exclusion Criteria:

  • Patients with previous open colorectal surgery (resections, enterostomies)
  • Individuals in need of long lasting attention and nursing services (somatic or psychosocial reasons, mental retardation)
  • On-going cytotoxic treatment or radiotherapy for malignant disease
  • Severe chronic cardiac or lung disease (NYHA III-IV)
  • Patients with heart valve replacement on life long anticoagulant therapy
  • A coronary event during the last 3 months if having lead to hospitalisation
  • Cerebrovascular accident during the last 3 months
  • Resident abroad
  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: NCT00119912

Locations
Norway
Institute of Population-based Cancer Research
Oslo, Norway, 0310
Sponsors and Collaborators
Norwegian Department of Health and Social Affairs
Norwegian Cancer Society
Investigators
Study Chair: Frøydis Langmark, M.D. Institute of Population-based Cancer Research
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Norwegian Department of Health and Social Affairs
ClinicalTrials.gov Identifier: NCT00119912     History of Changes
Other Study ID Numbers: NORCCAP-1, Shdir 97/08614
Study First Received: July 6, 2005
Last Updated: January 7, 2013
Health Authority: Norway: Directorate of Health

Keywords provided by Norwegian Department of Health and Social Affairs:
screening
flexible sigmoidoscopy
fecal occult blood
cancer
colon
rectum

Additional relevant MeSH terms:
Adenoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 28, 2014