Advanced Colorectal CancerNCT07470658
Optimal Surveillance Strategy After Positive FIT and Negative Colonoscopy
An observational study of Advanced Colorectal Cancer and Colo-rectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Individuals with high fecal hemoglobin concentrations detected by fecal immunochemical testing (FIT) but negative findings on high-quality colonoscopy represent a clinically challenging population. Read more about this study
- Who is it for?
- Ages 45 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Colorectal Cancer, Colo-rectal Cancer, Fecal Immunochemical Test
- What is being tested?
- Colonoscopy Surveillance
- How many people
- 1,274 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Mar 2026to 31 Oct 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 45 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Gastroenterology outpatient clinic at National Taiwan University Hospital and Cancer Hospital
Who may be able to join
- Age 45-74 years
- Quantitative FIT result with fecal hemoglobin ≥100 µg/g within the past two years
- Negative high-quality colonoscopy following the positive FIT result
- Ability to provide written informed consent
Who cannot join
- History of colorectal cancer
- Inflammatory bowel disease
- Known hereditary colorectal cancer syndrome
- Life expectancy less than five years
- Inability or unwillingness to undergo colonoscopy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: From Uncertainty to Evidence: A Randomized Controlled Trial for Optimal Surveillance in High-Risk Colonoscopy-Negative Individuals After Positive FIT
Individuals with high fecal hemoglobin concentrations detected by fecal immunochemical testing (FIT) but negative findings on high-quality colonoscopy represent a clinically challenging population. Although colonoscopy is considered the gold standard diagnostic procedure, previous studies suggest that these individuals may still have an elevated long-term risk of colorectal cancer.
This randomized controlled trial aims to determine the optimal surveillance strategy for this high-risk group by comparing two approaches: repeat FIT testing after two years versus direct colonoscopy after two years.
Read the detailed description
In colorectal cancer screening programs based on fecal immunochemical testing (FIT), a subgroup of individuals presents with strongly positive FIT results but negative findings on subsequent high-quality colonoscopy. Despite the absence of detected adenomas or cancer, these individuals may remain at increased risk of colorectal cancer.
Currently, there is no consensus guideline regarding the optimal follow-up strategy for this population. Some clinicians recommend repeat colonoscopy, while others prefer non-invasive monitoring using FIT.
This pragmatic randomized controlled trial will compare two surveillance strategies:
Repeat FIT testing two years after enrollment
Direct colonoscopy two years after enrollment
The primary objective is to compare the detection rate of advanced colorectal neoplasia (ACN) between the two strategies. The results of this study may help establish evidence-based surveillance guidelines for this high-risk population.
- Being tested
- Colonoscopy Surveillance
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy SurveillanceDiagnostic test
Participants will undergo direct colonoscopy two years after enrollment regardless of FIT results.
| Study group | Role | What they receive |
|---|---|---|
| FIT Surveillance | Participants will undergo repeat fecal immunochemical testing two years after enrollment. Colonoscopy will only be recommended if the repeat FIT result is positive. Receives: Diagnostic Test: Colonoscopy Surveillance | |
| Colonoscopy Surveillance | Participants will undergo direct colonoscopy two years after enrollment regardless of FIT results. Receives: Diagnostic Test: Colonoscopy Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of advanced colorectal neoplasia (ACN)
ACN is defined as colorectal cancer or advanced adenoma (adenoma ≥10 mm, villous histology, or high-grade dysplasia).
Measured: 2 years
Secondary outcomes (4)
Detection rate of any adenoma
Measured: 2 years
Detection rate of colorectal cancer
Measured: 2 years
Screening compliance rate
Measured: 2 years
Cost-effectiveness comparison between surveillance strategies
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start10 Mar 2026
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,274 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470658
- Sponsor's protocol ID
- 202508171RINA
- Status last verified
- Nov 2025
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Uncertainty to Evidence: A Randomized Controlled Trial for Optimal Surveillance in High-Risk Colonoscopy-Negative Individuals After Positive FIT
- ClinicalTrials.gov ID
- NCT07470658
- Acronym / sponsor ID
- 202508171RINA
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,274 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 13 Mar 2026 (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.
Individuals with high fecal hemoglobin concentrations detected by fecal immunochemical testing (FIT) but negative findings on high-quality colonoscopy represent a clinically challenging population. Although colonoscopy is considered the gold standard diagnostic procedure, previous studies suggest that these individuals may still have an elevated long-term risk of colorectal cancer.
This randomized controlled trial aims to determine the optimal surveillance strategy for this high-risk group by comparing two approaches: repeat FIT testing after two years versus direct colonoscopy after two years.
Detailed description
In colorectal cancer screening programs based on fecal immunochemical testing (FIT), a subgroup of individuals presents with strongly positive FIT results but negative findings on subsequent high-quality colonoscopy. Despite the absence of detected adenomas or cancer, these individuals may remain at increased risk of colorectal cancer.
Currently, there is no consensus guideline regarding the optimal follow-up strategy for this population. Some clinicians recommend repeat colonoscopy, while others prefer non-invasive monitoring using FIT.
This pragmatic randomized controlled trial will compare two surveillance strategies:
Repeat FIT testing two years after enrollment
Direct colonoscopy two years after enrollment
The primary objective is to compare the detection rate of advanced colorectal neoplasia (ACN) between the two strategies. The results of this study may help establish evidence-based surveillance guidelines for this high-risk population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FIT Surveillance | – | Diagnostic Test: Colonoscopy SurveillanceParticipants will undergo repeat fecal immunochemical testing two years after enrollment. Colonoscopy will only be recommended if the repeat FIT result is positive. |
| Colonoscopy Surveillance | – | Diagnostic Test: Colonoscopy SurveillanceParticipants will undergo direct colonoscopy two years after enrollment regardless of FIT results. |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Gastroenterology outpatient clinic at National Taiwan University Hospital and Cancer Hospital
Key inclusion criteria (4 listed)
- Age 45-74 years
- Quantitative FIT result with fecal hemoglobin ≥100 µg/g within the past two years
- Negative high-quality colonoscopy following the positive FIT result
- Ability to provide written informed consent
Key exclusion criteria (5 listed)
- History of colorectal cancer
- Inflammatory bowel disease
- Known hereditary colorectal cancer syndrome
- Life expectancy less than five years
- Inability or unwillingness to undergo colonoscopy
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 |
|---|---|---|
| Colonoscopy SurveillanceParticipants will undergo direct colonoscopy two years after enrollment regardless of FIT results. | Diagnostic test | Colonoscopy Surveillance, FIT Surveillance |
Primary outcome
Detection rate of advanced colorectal neoplasia (ACN)
Time frame: 2 years
ACN is defined as colorectal cancer or advanced adenoma (adenoma ≥10 mm, villous histology, or high-grade dysplasia).
4 secondary outcomes
Detection rate of any adenoma
Time frame: 2 years
Detection rate of colorectal cancer
Time frame: 2 years
Screening compliance rate
Time frame: 2 years
Cost-effectiveness comparison between surveillance strategies
Time frame: 2 years
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 13 Mar 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Colorectal Cancer and Colo-rectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 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: enrolling by invitation, as of the sponsor's last update on 13 Mar 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 Taiwan. 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?
Detection rate of advanced colorectal neoplasia (ACN) (time frame: 2 years). 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 13 Mar 2026.