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Optimal Surveillance Strategy After Positive FIT and Negative Colonoscopy

NCT07470658 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 1274

Last updated 2026-03-13

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Colonoscopy Surveillance

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

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Eligibility

Min Age
45 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-10
Primary Completion
2029-10-31
Completion
2029-10-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07470658 on ClinicalTrials.gov