Optimal Surveillance Strategy After Positive FIT and Nega... | NCT07470658

Studies
Optimal Surveillance Strategy After Positive FIT and Negative Colonoscopy

NCT07470658

Sponsor

National Taiwan University Hospital

Status

Enrolling by invitation

Last Update Posted

Mar 13, 2026Actual

Enrollment

1,274Estimated

Phase

Not provided

Conditions

Advanced Colorectal Cancer
Colo-rectal Cancer
Fecal Immunochemical Test

Interventions

Colonoscopy Surveillance

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2026Actual

Primary Completion Date

Oct 31, 2029Estimated

Completion Date

Oct 31, 2029Estimated

First Submitted Date

Mar 10, 2026

First Submission Date that Met QC Criteria

Mar 10, 2026

First Posted Date

Mar 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2026

Last Update Posted Date

Mar 13, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

National Taiwan University Clinical Trial Center, Visiting Staff, National Taiwan University HospitalPrincipal Investigator

Lead Sponsor

National Taiwan University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,274Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Diagnostic Test: Colonoscopy Surveillance
Colonoscopy Surveillance		Participants will undergo direct colonoscopy two years after enrollment regardless of FIT results.	Diagnostic Test: Colonoscopy Surveillance

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colonoscopy Surveillance	Diagnostic Test	Participants will undergo direct colonoscopy two years after enrollment regardless of FIT results.	Colonoscopy Surveillance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	2 years

Secondary Outcomes

Measure	Description	Time Frame
Detection rate of any adenoma		2 years
Detection rate of colorectal cancer		2 years
Screening compliance rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

History of colorectal cancer
Inflammatory bowel disease
Known hereditary colorectal cancer syndrome
Life expectancy less than five years
Inability or unwillingness to undergo colonoscopy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Gastroenterology outpatient clinic at National Taiwan University Hospital and Cancer Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		100	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

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Browse Branches

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