Colorectal CancerNORCCAPNCT00119912
NORCCAP: Norwegian Colorectal Cancer Prevention Trial
A study testing A 1 Intervention arm Flex Sig and A 2 Intervention arm Flex Sig + iFOBT in people with Colorectal Cancer and Adenoma, run by Norwegian Institute of Public Health at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Adenoma
- What is being tested?
- A 1 Intervention arm Flex Sig and A 2 Intervention arm Flex Sig + iFOBT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100,000 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 1999to Dec 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women
- Living in Oslo or Telemark
- Age 50-64 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Norwegian Colorectal Cancer Prevention Trial
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.
Read the 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:
- 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
- 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
- Determine the prevalence of known types familial CRC in a general population and try to define other groups with intermediate increased risk
- 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).
- Conditions
- Colorectal Cancer, Adenoma
- Being tested
- A 1 Intervention arm Flex Sig, A 2 Intervention arm Flex Sig + iFOBT
- Keywords
- screening, flexible sigmoidoscopy, fecal occult blood, cancer, colon, rectum
- Medical subject headings
- Colorectal Neoplasms, Adenoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A 1 Intervention arm Flex SigProcedure or surgery
Screening by flexible sigmoidoscopy
A 2 Intervention arm Flex Sig + iFOBTProcedure or surgery
In addition to Flexible Sigmoidoscopy, half of arm A (randomised 1:1) is invited to provide stool samples for FOBT
| Study group | Role | What they receive |
|---|---|---|
| A 1 Intervention arm Flex Sig | Active comparator | Randomised from the population registry, age 50-64 years and invited for Flexible Sigmoidoscopy (Flex Sig) screening. Half of invitees are additionally invited to provide a stool sample for fecal occult blood testing (Intervention arm A 2). They are drawn directly from the population registry without prior consent to be randomized - approved by Regional Ethics Committees of South-East Norway.. Receives: Procedure: A 1 Intervention arm Flex Sig |
| B Control arm | No intervention | "No screening group" randomised from population age 50-64 years. As for the active intervention arm, the control group was not informed about being randomized to 'no screening' since 'no screening' was the current usual care (and still is in 2015) in Norway - approved by Regional Ethics Committees of South-East Norway. |
| A 2 Intervention arm Flex Sig + iFOBT | Active comparator | Randomised from the population registry, age 50-64 years and invited for Flexible Sigmoidoscopy (Flex Sig) screening plus an immunochemical test for fecal occult blood (iFOBT). As for arms A 1 and B, they are drawn directly from the population registry without prior consent to be randomized. Receives: Procedure: A 2 Intervention arm Flex Sig + iFOBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
CRC incidence and mortality is followed
Measured: Evaluations in 2007 (published),2012,2017
Secondary outcomes (2)
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.
Determine the prevalence of familial CRC in a general population sample
Measured: Evaluated in 2005 (published)
2. Clarify possible psychosocial effects of endoscopic screening and how it may influence lifestyle and lifestyle related morbidity and overall mortality. Evaluation in 2005.
Determine psychosocial effects of invitation to screening and of screening findings
Measured: Evaluated in 2005 (published)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study start1 Jan 1999
- Primary completionDec 2036 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- Norwegian Cancer Society
- Responsible party
- Sponsor
- Investigators
- Giske Ursin, M.D., Study chair, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119912
- Sponsor's protocol ID
- NORCCAP-1
- Other IDs
- Shdir 97/08614
- Acronym
- NORCCAP
- Status last verified
- Mar 2026
- First submitted
- 6 Jul 2005
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hoff G, Grotmol T, Skovlund E, Bretthauer M; Norwegian Colorectal Cancer Prevention Study Group. Risk of colorectal cancer seven years after flexible sigmoidoscopy screening: randomised controlled trial. BMJ. 2009 May 29;338:b1846. doi: 10.1136/bmj.b1846.
PubMed 19483252Holme O, Bretthauer M, Eide TJ, Loberg EM, Grzyb K, Loberg M, Kalager M, Adami HO, Kjellevold O, Hoff G. Long-term risk of colorectal cancer in individuals with serrated polyps. Gut. 2015 Jun;64(6):929-36. doi: 10.1136/gutjnl-2014-307793. Epub 2014 Nov 16.
PubMed 25399542Berstad P, Loberg M, Larsen IK, Kalager M, Holme O, Botteri E, Bretthauer M, Hoff G. Long-term lifestyle changes after colorectal cancer screening: randomised controlled trial. Gut. 2015 Aug;64(8):1268-76. doi: 10.1136/gutjnl-2014-307376. Epub 2014 Sep 2.
PubMed 25183203Holme O, Loberg M, Kalager M, Bretthauer M, Hernan MA, Aas E, Eide TJ, Skovlund E, Schneede J, Tveit KM, Hoff G. Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: a randomized clinical trial. JAMA. 2014 Aug 13;312(6):606-15. doi: 10.1001/jama.2014.8266.
PubMed 25117129Larsen 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.
PubMed 17363335Larsen IK, Grotmol T, Almendingen K, Hoff G. Lifestyle as a predictor for colonic neoplasia in asymptomatic individuals. BMC Gastroenterol. 2006 Jan 13;6:5. doi: 10.1186/1471-230X-6-5.
PubMed 16412216Larsen IK, Grotmol T, Almendingen K, Hoff G. Lifestyle characteristics among participants in a Norwegian colorectal cancer screening trial. Eur J Cancer Prev. 2006 Feb;15(1):10-9. doi: 10.1097/01.cej.0000186636.27496.bb.
PubMed 16374224Stormorken AT, Hoff G, Norstein J, Bowitz-Lothe IM, Hanslien E, Grindedal E, Moller P. Estimated prevalence of hereditary cancers and the need for surveillance in a Norwegian county, Telemark. Scand J Gastroenterol. 2006 Jan;41(1):71-9. doi: 10.1080/00365520510023891.
PubMed 16373279Gondal G, Grotmol T, Hofstad B, Bretthauer M, Eide TJ, Hoff G. Biopsy of colorectal polyps is not adequate for grading of neoplasia. Endoscopy. 2005 Dec;37(12):1193-7. doi: 10.1055/s-2005-921031.
PubMed 16329016Gondal G, Grotmol T, Hofstad B, Bretthauer M, Eide TJ, Hoff G. Lifestyle-related risk factors and chemoprevention for colorectal neoplasia: experience from the large-scale NORCCAP screening trial. Eur J Cancer Prev. 2005 Aug;14(4):373-9. doi: 10.1097/00008469-200508000-00010.
PubMed 16030428Skovlund E, Bretthauer M, Grotmol T, Larsen IK, Hoff G. Sensitivity of pain rating scales in an endoscopy trial. Clin J Pain. 2005 Jul-Aug;21(4):292-6. doi: 10.1097/01.ajp.0000110636.14355.3e.
PubMed 15951645Hoff G, Grotmol T, Thiis-Evensen E, Bretthauer M, Gondal G, Vatn MH. Testing for faecal calprotectin (PhiCal) in the Norwegian Colorectal Cancer Prevention trial on flexible sigmoidoscopy screening: comparison with an immunochemical test for occult blood (FlexSure OBT). Gut. 2004 Sep;53(9):1329-33. doi: 10.1136/gut.2004.039032.
PubMed 15306594Bretthauer M, Skovlund E, Grotmol T, Thiis-Evensen E, Gondal G, Huppertz-Hauss G, Efskind P, Hofstad B, Thorp Holmsen S, Eide TJ, Hoff G. Inter-endoscopist variation in polyp and neoplasia pick-up rates in flexible sigmoidoscopy screening for colorectal cancer. Scand J Gastroenterol. 2003 Dec;38(12):1268-74. doi: 10.1080/00365520310006513.
PubMed 14750648Bretthauer M, Hoff GS, Thiis-Evensen E, Huppertz-Hauss G, Skovlund E. Air and carbon dioxide volumes insufflated during colonoscopy. Gastrointest Endosc. 2003 Aug;58(2):203-6. doi: 10.1067/mge.2003.340.
PubMed 12872086Gondal G, Grotmol T, Hofstad B, Bretthauer M, Eide TJ, Hoff G. The Norwegian Colorectal Cancer Prevention (NORCCAP) screening study: baseline findings and implementations for clinical work-up in age groups 50-64 years. Scand J Gastroenterol. 2003 Jun;38(6):635-42. doi: 10.1080/00365520310003002.
PubMed 12825872
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norwegian Colorectal Cancer Prevention Trial
- ClinicalTrials.gov ID
- NCT00119912
- Acronym / sponsor ID
- NORCCAP / NORCCAP-1
- Conditions
- Colorectal Cancer, Adenoma
- Keywords
- screening, flexible sigmoidoscopy, fecal occult blood, cancer, colon, rectum
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100,000 participants (actual)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- Norwegian Cancer Society
- Study start
- 1 Jan 1999 (actual)
- Primary completion
- Dec 2036 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 14 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
- 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
- Determine the prevalence of known types familial CRC in a general population and try to define other groups with intermediate increased risk
- 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A 1 Intervention arm Flex Sig | Active comparator | Procedure: A 1 Intervention arm Flex SigRandomised from the population registry, age 50-64 years and invited for Flexible Sigmoidoscopy (Flex Sig) screening. Half of invitees are additionally invited to provide a stool sample for fecal occult blood testing (Intervention arm A 2). They are drawn directly from the population registry without prior consent to be randomized - approved by Regional Ethics Committees of South-East Norway.. |
| B Control arm | No intervention | –"No screening group" randomised from population age 50-64 years. As for the active intervention arm, the control group was not informed about being randomized to 'no screening' since 'no screening' was the current usual care (and still is in 2015) in Norway - approved by Regional Ethics Committees of South-East Norway. |
| A 2 Intervention arm Flex Sig + iFOBT | Active comparator | Procedure: A 2 Intervention arm Flex Sig + iFOBTRandomised from the population registry, age 50-64 years and invited for Flexible Sigmoidoscopy (Flex Sig) screening plus an immunochemical test for fecal occult blood (iFOBT). As for arms A 1 and B, they are drawn directly from the population registry without prior consent to be randomized. |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men and women
- Living in Oslo or Telemark
- Age 50-64 years
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A 1 Intervention arm Flex SigScreening by flexible sigmoidoscopy | Procedure or surgery | A 1 Intervention arm Flex Sig |
| A 2 Intervention arm Flex Sig + iFOBTIn addition to Flexible Sigmoidoscopy, half of arm A (randomised 1:1) is invited to provide stool samples for FOBT | Procedure or surgery | A 2 Intervention arm Flex Sig + iFOBT |
Primary outcome
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
CRC incidence and mortality is followed
2 secondary outcomes
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Background: PubMed 19483252Hoff G, Grotmol T, Skovlund E, Bretthauer M; Norwegian Colorectal Cancer Prevention Study Group. Risk of colorectal cancer seven years after flexible sigmoidoscopy screening: randomised controlled trial. BMJ. 2009 May 29;338:b1846. doi: 10.1136/bmj.b1846.
- Background: PubMed 25399542Holme O, Bretthauer M, Eide TJ, Loberg EM, Grzyb K, Loberg M, Kalager M, Adami HO, Kjellevold O, Hoff G. Long-term risk of colorectal cancer in individuals with serrated polyps. Gut. 2015 Jun;64(6):929-36. doi: 10.1136/gutjnl-2014-307793. Epub 2014 Nov 16.
- Background: PubMed 25183203Berstad P, Loberg M, Larsen IK, Kalager M, Holme O, Botteri E, Bretthauer M, Hoff G. Long-term lifestyle changes after colorectal cancer screening: randomised controlled trial. Gut. 2015 Aug;64(8):1268-76. doi: 10.1136/gutjnl-2014-307376. Epub 2014 Sep 2.
- Background: PubMed 25117129Holme O, Loberg M, Kalager M, Bretthauer M, Hernan MA, Aas E, Eide TJ, Skovlund E, Schneede J, Tveit KM, Hoff G. Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: a randomized clinical trial. JAMA. 2014 Aug 13;312(6):606-15. doi: 10.1001/jama.2014.8266.
- Results publication: PubMed 17363335Larsen 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.
- Results publication: PubMed 16412216Larsen IK, Grotmol T, Almendingen K, Hoff G. Lifestyle as a predictor for colonic neoplasia in asymptomatic individuals. BMC Gastroenterol. 2006 Jan 13;6:5. doi: 10.1186/1471-230X-6-5.
- Results publication: PubMed 16374224Larsen IK, Grotmol T, Almendingen K, Hoff G. Lifestyle characteristics among participants in a Norwegian colorectal cancer screening trial. Eur J Cancer Prev. 2006 Feb;15(1):10-9. doi: 10.1097/01.cej.0000186636.27496.bb.
- Results publication: PubMed 16373279Stormorken AT, Hoff G, Norstein J, Bowitz-Lothe IM, Hanslien E, Grindedal E, Moller P. Estimated prevalence of hereditary cancers and the need for surveillance in a Norwegian county, Telemark. Scand J Gastroenterol. 2006 Jan;41(1):71-9. doi: 10.1080/00365520510023891.
- Results publication: PubMed 16329016Gondal G, Grotmol T, Hofstad B, Bretthauer M, Eide TJ, Hoff G. Biopsy of colorectal polyps is not adequate for grading of neoplasia. Endoscopy. 2005 Dec;37(12):1193-7. doi: 10.1055/s-2005-921031.
- Results publication: PubMed 16030428Gondal G, Grotmol T, Hofstad B, Bretthauer M, Eide TJ, Hoff G. Lifestyle-related risk factors and chemoprevention for colorectal neoplasia: experience from the large-scale NORCCAP screening trial. Eur J Cancer Prev. 2005 Aug;14(4):373-9. doi: 10.1097/00008469-200508000-00010.
- Results publication: PubMed 15951645Skovlund E, Bretthauer M, Grotmol T, Larsen IK, Hoff G. Sensitivity of pain rating scales in an endoscopy trial. Clin J Pain. 2005 Jul-Aug;21(4):292-6. doi: 10.1097/01.ajp.0000110636.14355.3e.
- Results publication: PubMed 15306594Hoff G, Grotmol T, Thiis-Evensen E, Bretthauer M, Gondal G, Vatn MH. Testing for faecal calprotectin (PhiCal) in the Norwegian Colorectal Cancer Prevention trial on flexible sigmoidoscopy screening: comparison with an immunochemical test for occult blood (FlexSure OBT). Gut. 2004 Sep;53(9):1329-33. doi: 10.1136/gut.2004.039032.
- Website for the Norwegian Cancer RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giske Ursin, M.D. study chair
Norwegian Institute of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A 1 Intervention arm Flex Sig and A 2 Intervention arm Flex Sig + iFOBT in people with Colorectal Cancer and Adenoma, run by Norwegian Institute of Public Health at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00119912, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.