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NORCCAP: Norwegian Colorectal Cancer Prevention Trial

Study acronym: NORCCAP
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Notable

    Lead sponsor: Norwegian Department of Health and Social Affairs to Norwegian Institute of Public Health

    Start date: Jan 1999 to Jan 1, 1999

    Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locationsv11

  2. Minor

    2 amendments

    2 re-verifications since 2019-09-06, no change to tracked fields

    v9-v10

  3. Notable

    Primary and study completion dates: Dec 2017 to Dec 2036

    Study Statusv8

  4. Notable

    Phase: Phase 2/3 to Not applicable

    Primary and study completion dates: Mar 2017 to Dec 2017; Secondary endpoints: details revised at 2 of 2 entries

    Study Status, Study Design, Outcome Measuresv7

  5. Notable

    Primary completion date: Mar 2013 to Mar 2017

    Completion date: Jan 2017 to Mar 2017; Interventions: Fecal Occult Blood Test (FOBT) screening (Procedure), Flexible sigmoidoscopy (Procedure) to A 1 Intervention arm Flex Sig (Procedure), A 2 Intervention arm Flex Sig + iFOBT (Procedure); Publications: details revised at 3 of 30 entries; and 1 more

    Show all 5 changes in this update
    • Notable Primary completion date: Mar 2013 to Mar 2017
    • Minor Completion date: Jan 2017 to Mar 2017
    • Minor Interventions: Fecal Occult Blood Test (FOBT) screening (Procedure), Flexible sigmoidoscopy (Procedure) to A 1 Intervention arm Flex Sig (Procedure), A 2 Intervention arm Flex Sig + iFOBT (Procedure)
    • Minor Publications: details revised at 3 of 30 entries
    • Minor Study arms: 2 to 3

    Study Status, Arms and Interventions, Referencesv6

Show 4 earlier versions

  1. Notable

    Primary endpoints: 3 to 1

    Primary completion date: Mar 2013; Study description shortened, about 1 word; Publications: details revised at 1 of 30 entries

    Show what changed: Primary endpoints
    2. 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. First evaluation after 5 years. 3. To evaluate to which extent (and in which direction) the study may influence overall endoscopic activ [...]
    Show what changed: Study description
    [...] ed trials with long-term follow-up are missing. The primary aimsaim areis asto follows: Evaluateevaluate the effect on CRC mortality and morbidity by screen detecti [...] al of precursor lesions (polypectomy of adenomatous polyps) Secondary aims: Evaluation of cost/effectiveness of screening for CRC and si [...] and in areas where controlled screening is not established Secondary aims: Determine the prevalence of known types familial CRC in a ge [...]

    Study Identification, Study Status, Sponsor/Collaborators, Study Description, Outcome Measures, Referencesv5

  2. Minor

    Study Status, References

    Re-verified, no change to tracked fields

    v4

  3. Notable

    Primary endpoints revised (3)

    Completion date: Jan 2002 to Jan 2017; Interventions: Fecal Occult Blood Test (FOBT) screening (Procedure), Flexible sigmoidoscopy screening (Procedure) to Fecal Occult Blood Test (FOBT) screening (Procedure), Flexible sigmoidoscopy (Procedure); Secondary endpoints: details revised at 2 of 2 entries; and 2 more

    Show all 6 changes in this update
    • Notable Primary endpoints revised (3)
      Show what changed
      [...] only compared to flex-sig in combination with faecal tests. ForstFirst evaluation after 5 years. 3. To evaluate to which extent (a [...] and in areas where controlled screening is not established.First evaluation after 5 years.
    • Minor Completion date: Jan 2002 to Jan 2017
    • Minor Interventions: Fecal Occult Blood Test (FOBT) screening (Procedure), Flexible sigmoidoscopy screening (Procedure) to Fecal Occult Blood Test (FOBT) screening (Procedure), Flexible sigmoidoscopy (Procedure)
    • Minor Secondary endpoints: details revised at 2 of 2 entries
    • Minor Publications: 12 to 30
      Show what changed
      Larsen IK, Grotmol T, Almendingen K, Hoff G. Impact of colorectal cancer screening on future lifestyle choices: a three-year randomized controlled trial. Clin Gastroenterol Hepatol. 2007 Apr;5(4):477-83. doi: 10.1016/j.cgh.2006.12.011. Epub 2007 Mar 23. Larsen IK, Grotmol T, Almendingen K, Hoff G. L [...]
    • Minor Study arms: 0 to 2

    Study Status, Oversight, Study Design, Arms and Interventions, Outcome Measures, Referencesv3

  4. Minor

    Study Status

    Re-verified, no change to tracked fields

    v2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00119912
Lead Sponsor Norwegian Institute of Public Health
Collaborators: Norwegian Cancer Society
Conditions Colorectal Cancer, Adenoma
Enrollment 100,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov