Colorectal NeoplasmsNCT06983639
Randomized Trial Comparing Fecal Testing (FIT) to Colonoscopy for Post-polypectomy Surveillance
A study testing Fecal occult blood testing and Colonoscopy in people with Colorectal Neoplasms, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
From observational studies, it is know that the risk of developing colorectal cancer after polyp removal is lower if the patients adheres to surveillance recommendations. However, colonoscopy is burdensome for patients and colonoscopy availability is limited in many parts of the world. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Fecal occult blood testing and Colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteNorway
- Study dates
- 9 Jan 2026to 1 Jan 2050
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High-quality baseline colonoscopy with adequat cleansing and cecal intubation
- Remocval of at least one advanced adenoma
- Clean colon (all polyps removed)
- Signed informed consent
Who cannot join
- Colorectal cancer
- History of surgical colon resection for any reason
- Genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
- ≥ 10 adenomas at baseline colonoscopy (cumulative)
- History of advanced serrated lesion, defined as SSL≥ 10mm or with dysplasia
- Inflammatory bowel disease
- On-going palliative care for any reason
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Sørlandet sykehus HF
Arendal, Agder, 4838
Chief of gastroenterology, MD, 004792660445, johan.christian.holck-steen@sshf.no
About this study
Official title: FIT Versus Colonoscopy for Post-polypectomy Surveillance
From observational studies, it is know that the risk of developing colorectal cancer after polyp removal is lower if the patients adheres to surveillance recommendations. However, colonoscopy is burdensome for patients and colonoscopy availability is limited in many parts of the world. In addition, more than half of surveillance colonoscopies are without any findings. The trial investigates whether surveillance using fecal testing for blod is as good as colonoscopy after removal of colorectal polyps.
Read the detailed description
Colorectal cancer is the third most common cancer in the world and develops from benign colorectal polyps. Colonoscopy with polyp removal reduces colorectal cancer incidence and mortality. Patients who have had polyps removed are at increased risk for metachronous polyps and subsequent cancer and are referred to colonoscopic surveillance at regular intervals, the first one usually scheduled three years after polypectomy. Today, these comprise 15-25% of all colonoscopies, but in >85%, no high-risk pathology is found. Thus, post-polypectomy surveillance consumes major resources without benefit to the patients, and these resources are much needed for colonoscopies due to other indications in an aging population. Additionally, colonoscopy requires burdensome bowel-cleansing, discomfort during the examination, absenteeism from work and sometimes need for an escort. Severe complications like bleeding and perforation may occur. Overdiagnosis and overtreatment of benign lesions occur in a large proportion of examinations as most polyps will never develop into colorectal cancer, even if left untreated.
Sensitive fecal occult blood tests (FIT) have been developed that may detect colorectal cancer with the same sensitivity as colonoscopy. The test is cheap, is easily distributed by mail and may be performed at home. If the test detects blood, colonoscopy is indicated. FIT has been used in colorectal screening program for years, but has not yet been thoroughly investigated for post-polypectomy surveillance purposes.
The trial is a pragmatic non-inferiority randomized trial in which patients who are eligible for 3-year colonoscopic surveillance are offered either colonoscopy (standard care) or FIT followed by a colonoscopy in case of a positive test result (Figure 1). FIT may decrease colonoscopy surveillance demand by > 50%, which equals a cost saving of almost 30,000,000 Norwegian kroner annually. By proposing FIT for post-polypectomy surveillance, the trial introduce decentralized and personalized medical follow-up of these patients, and at the same time reduce work-absenteeism, patient discomfort, risk of complications and importantly: overdiagnosis and overtreatment of benign colorectal lesions.
- Conditions
- Colorectal Neoplasms
- Being tested
- Fecal occult blood testing, Colonoscopy
- Keywords
- surveillance, polyp
- Medical subject headings
- Colorectal Neoplasms, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal occult blood testingDiagnostic test
Fecal testing for blood as surveillance efter polyp removal
ColonoscopyDiagnostic test
Colonoscopy after polyp removal according to guidelines
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy | Active comparator | Colonoscopy surveillance after polyp removal Receives: Diagnostic Test: Colonoscopy |
| Fecal blood testing | Experimental | Fecal testing as surveillance after polypectomy Receives: Diagnostic Test: Fecal occult blood testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer incidence
Measured: 12 years from randomization
Secondary outcomes (9)
Colorctal cancer mortality
Measured: 12 years from randomization
Advanced neoplasia incidence
Findings of colorectal cancer and high-risk polyps
Measured: 3 years from randomization
Findings at colonoscopy
Pathology detected during colonoscopy in both arms
Measured: 12 years from randomization
Colonoscopy utilization
Number of colonoscopies performed
Measured: 12 years after randomization
Adherence
Adherence with colonoscopy and FIT surveillance recommendations. Proportion of participants in each arm who are invited for colonoscopy or FIT surveillance and who actually adheres submit the FIT/undergo colonoscopy.
Measured: 12 years from randomization
Cost-effectiveness
Total cost for FIT-surveillance and colonoscopy surveillance will be calculated and compared, including reimbursement (FIT, colonoscopy, pathology assessment), payment from patients, travel, absenteism from work, cost of complications etc.
Measured: 12 years from randomization
Adverse events
Adverse events after colonoscopy
Measured: 30 days after colonoscopy
Carbon footprint
The carbon footprint in each arm will be calculated and compared. Carbon footprint is the total carbon emission from manufacturing, shipping, use, prosessing, litter-handling etc
Measured: 12 years after randomization
FIT accuracy
Sensitivity, specificity, postive predictive value and negative predicitive value for colorectal cancer and advanced neoplasia at different FIT-thresholds
Measured: 3 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start9 Jan 2026
- Primary completion31 Dec 2040 (estimated)
- Study completion1 Jan 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- Sykehuset Ostfold, University Hospital, Akershus, Vestre Viken Hospital Trust, Sykehuset Telemark Hospital Trust, Helse Møre og Romsdal HF, St. Olavs Hospital, University Hospital of North Norway, Sykehuset i Vestfold HF, Helse Stavanger HF, Turku University Hospital, Helsinki University Central Hospital, Randers Regional Hospital, Viborg Regional Hospital, Gødstrup Hospital, Horsens Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983639
- Sponsor's protocol ID
- 744836
- Status last verified
- Jan 2026
- First submitted
- 6 May 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIT Versus Colonoscopy for Post-polypectomy Surveillance
- ClinicalTrials.gov ID
- NCT06983639
- Acronym / sponsor ID
- 744836
- Conditions
- Colorectal Neoplasms
- Keywords
- surveillance, polyp
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- Sykehuset Ostfold, University Hospital, Akershus, Vestre Viken Hospital Trust, Sykehuset Telemark Hospital Trust, Helse Møre og Romsdal HF, St. Olavs Hospital, University Hospital of North Norway, Sykehuset i Vestfold HF, Helse Stavanger HF, Turku University Hospital, Helsinki University Central Hospital, Randers Regional Hospital, Viborg Regional Hospital, Gødstrup Hospital, Horsens Hospital
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 31 Dec 2040 (estimated)
- Study completion
- 1 Jan 2050 (estimated)
- First posted
- 21 May 2025 (actual)
- 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.
From observational studies, it is know that the risk of developing colorectal cancer after polyp removal is lower if the patients adheres to surveillance recommendations. However, colonoscopy is burdensome for patients and colonoscopy availability is limited in many parts of the world. In addition, more than half of surveillance colonoscopies are without any findings. The trial investigates whether surveillance using fecal testing for blod is as good as colonoscopy after removal of colorectal polyps.
Detailed description
Colorectal cancer is the third most common cancer in the world and develops from benign colorectal polyps. Colonoscopy with polyp removal reduces colorectal cancer incidence and mortality. Patients who have had polyps removed are at increased risk for metachronous polyps and subsequent cancer and are referred to colonoscopic surveillance at regular intervals, the first one usually scheduled three years after polypectomy. Today, these comprise 15-25% of all colonoscopies, but in >85%, no high-risk pathology is found. Thus, post-polypectomy surveillance consumes major resources without benefit to the patients, and these resources are much needed for colonoscopies due to other indications in an aging population. Additionally, colonoscopy requires burdensome bowel-cleansing, discomfort during the examination, absenteeism from work and sometimes need for an escort. Severe complications like bleeding and perforation may occur. Overdiagnosis and overtreatment of benign lesions occur in a large proportion of examinations as most polyps will never develop into colorectal cancer, even if left untreated.
Sensitive fecal occult blood tests (FIT) have been developed that may detect colorectal cancer with the same sensitivity as colonoscopy. The test is cheap, is easily distributed by mail and may be performed at home. If the test detects blood, colonoscopy is indicated. FIT has been used in colorectal screening program for years, but has not yet been thoroughly investigated for post-polypectomy surveillance purposes.
The trial is a pragmatic non-inferiority randomized trial in which patients who are eligible for 3-year colonoscopic surveillance are offered either colonoscopy (standard care) or FIT followed by a colonoscopy in case of a positive test result (Figure 1). FIT may decrease colonoscopy surveillance demand by > 50%, which equals a cost saving of almost 30,000,000 Norwegian kroner annually. By proposing FIT for post-polypectomy surveillance, the trial introduce decentralized and personalized medical follow-up of these patients, and at the same time reduce work-absenteeism, patient discomfort, risk of complications and importantly: overdiagnosis and overtreatment of benign colorectal lesions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy | Active comparator | Diagnostic Test: ColonoscopyColonoscopy surveillance after polyp removal |
| Fecal blood testing | Experimental | Diagnostic Test: Fecal occult blood testingFecal testing as surveillance after polypectomy |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- High-quality baseline colonoscopy with adequat cleansing and cecal intubation
- Remocval of at least one advanced adenoma
- Clean colon (all polyps removed)
- Signed informed consent
Key exclusion criteria (7 listed)
- Colorectal cancer
- History of surgical colon resection for any reason
- Genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
- ≥ 10 adenomas at baseline colonoscopy (cumulative)
- History of advanced serrated lesion, defined as SSL≥ 10mm or with dysplasia
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 |
|---|---|---|
| Fecal occult blood testingFecal testing for blood as surveillance efter polyp removal | Diagnostic test | Fecal blood testing |
| ColonoscopyColonoscopy after polyp removal according to guidelines | Diagnostic test | Colonoscopy |
Primary outcome
Colorectal cancer incidence
Time frame: 12 years from randomization
9 secondary outcomes
Colorctal cancer mortality
Time frame: 12 years from randomization
Advanced neoplasia incidence
Time frame: 3 years from randomization
Findings at colonoscopy
Time frame: 12 years from randomization
Colonoscopy utilization
Time frame: 12 years after randomization
Adherence
Time frame: 12 years from randomization
Cost-effectiveness
Time frame: 12 years from randomization
Adverse events
Time frame: 30 days after colonoscopy
Carbon footprint
Time frame: 12 years after randomization
FIT accuracy
Time frame: 3 years after randomization
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 15 Jan 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal occult blood testing and Colonoscopy in people with Colorectal Neoplasms, run by Sorlandet Hospital HF 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 15 Jan 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?
Contact Øyvind Holme (004738073000, oyvind.holme@sshf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal cancer incidence (time frame: 12 years from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2026.