ULTRA-high-risk Surveillance to Avoid Future Events: the ULTRA-SAFE Trial
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
The ULTRA-SAFE clinical trial is a prospective, randomized study designed to address the limitations of current "one-size-fits-all" colorectal cancer surveillance guidelines. While international standards recommend a three-year follow-up colonoscopy for all high-risk patients, data suggests that those with multiple advanced adenomas face a significantly higher recurrence risk (20%) compared to those with only low-risk adenomas (9%). To provide more personalized care, the trial compares a Standard Arm (colonoscopy at year three) against a FIT Arm, where participants undergo annual fecal immunochemical testing in years one and two. A positive FIT triggers an earlier colonoscopy, with the goal of reducing the 3-year prevalence of metachronous advanced colorectal neoplasms (meta-ACRN) from 20% to approximately 12.7%. The study has enrolled roughly 940 participants to statistically validate whether this early screening intervention can effectively prevent future malignant events in ultra-high-risk populations.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 40-75 lat
- •Stwierdzenie i usunięcie co najmniej dwóch poważnych polipaków podczas pierwszej kolonoskopii
- •Gotowość do uczestnictwa w badaniu i wykonywania badań zgodnie z planem
✗ Disqualifies
- •Wiek poniżej 40 lub powyżej 75 lat
- •Choroba zapalna jelit (IBD), rodzinna polipoza grubego jelita (FAP) lub dziedziczne zespoły raka
- •Historia raka jelita grubego
- •Bezpieczeństwo zdrowotne pacjenta - sytuacje, w których usuwanie polipaków nie jest bezpieczne
- •Brak co najmniej dwóch poważnych polipaków podczas pierwszej kolonoskopii
- •Więcej niż 10 łagodnych polipaków
- •Ciąża
Simplified criteria — AI translation
Trial details
- Minimum age
- 40 Years
- Maximum age
- 75 Years
- Last updated (source)
- August 26, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (4)
National Taiwan University Hospital
Taipei, Taiwan
National Taiwan University Hospital Hsinchu Branch
Hsinchu, Taiwan
Fu Jen Catholic University Hospital
New Taipei City, Taiwan
National Taiwan University Cancer Center
Taipei, Taiwan
Trial contact
Wei-Yuan Chang, MS
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/27/2026.
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