ClinicalTrials.gov
Cure8 trial brief
Non-Invasive Biomarker Monitoring in UC on Biologics
Tests and monitoring
Infliximab
Vedolizumab
Anti-TNF
Anti Integrin
Biomarkers
AI and data science
Fecal calprotectin
Why This Matters
If VOCs can reliably indicate biologic drug levels or disease activity, patients on IV biologics might one day have faster, non-invasive monitoring between infusions. That could help identify low drug levels or flares sooner without extra blood draws or delays.
Who Should Pay Attention
Adults with ulcerative colitis on maintenance infliximab or vedolizumab, clinicians managing biologic therapy, and researchers interested in VOC biomarkers, microbiome assays, and machine-learning diagnostics.
Study Snapshot
Story typeClinical Reference
Evidence typeClinical trial
Enrollment99 participants
Study statusNot_yet_recruiting
Source depthTrial registry record
What To Know
This trial is observational (not yet recruiting) and enrolls adults with established UC receiving maintenance IV infliximab or vedolizumab at a single UK center.
The study collects paired stool, urine, and blood samples timed to routine infusions and performs VOC analysis alongside standard lab measures (drug troughs, anti-drug antibodies, CRP, calprotectin) and microbiome and methylation assays.
The main goal is to see if a rapid, non-invasive VOC test could signal drug levels or disease activity, potentially offering faster information than current blood-based trough testing. Machine-learning models will be evaluated and the study is powered to detect a modest predictive accuracy (AUROC ≥0.70 considered acceptable).
No changes to patient treatment are made as part of the study; samples are stored and analyzed centrally. Results, if positive, would still require further validation before clinical use.
Keep In Mind
This is a single-centre, observational, not-yet-recruiting trial with planned machine-learning analyses; findings will be preliminary and require external validation. The registry record describes planned methods and outcomes but not results. SummaryConfidence: high.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorUniversity Hospitals Coventry and Warwickshire NHS Trust
Trial IDNCT07920367
Study typeObservational
Enrollment99 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedNov 5, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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