Optimal Surveillance Strategy After Positive FIT and Negative Colonoscopy

NCT07470658 | Enrolling By Invitation

• 1 other identifier: 202508171RINA
• Study Type: observational
• Target: 1,274
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Colorectal Cancer; Colo-rectal Cancer; Fecal Immunochemical Test

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• Detection rate of any adenoma

  2 years

• Detection rate of colorectal cancer

  2 years

• Screening compliance rate

  2 years

• Cost-effectiveness comparison between surveillance strategies

  2 years

Study Arms (2)

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

Colonoscopy Surveillance DIAGNOSTIC_TEST

Participants will undergo direct colonoscopy two years after enrollment regardless of FIT results.

Colonoscopy Surveillance; FIT Surveillance

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Gastroenterology outpatient clinic at National Taiwan University Hospital and Cancer Hospital

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Staff

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: March 13, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TW (1)