Non-Invasive Biomarker Monitoring in UC on Biologics
NCT07920367, Not yet recruiting, University Hospitals Coventry and Warwickshire NHS Trust
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Non-Invasive Biomarker Monitoring in UC on Biologics | ClinicalTrials.gov |
| NCT number | NCT07920367 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 99 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Hospitals Coventry and Warwickshire NHS Trust | ClinicalTrials.gov |
| Conditions | Ulcerative Colitis | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Faecal VOC discrimination of therapeutic versus sub-therapeutic biologic trough concentration | From enrollment to the end of treatment at 8 weeks | Cross-validated AUROC (95% CI) of the pre-specified machine-learning framework. Sensitivity, specificity, PPV and NPV also reported. | ClinicalTrials.gov |
| Secondary | Urinary VOC discrimination of therapeutic versus sub-therapeutic trough concentration (cross-validated AUROC, 95% CI) | From enrollment to the end of treatment at 8 weeks | ClinicalTrials.gov | |
| Secondary | Change in cross-validated AUROC when VOC features are added to models containing FCP, CRP and cytokines | From enrollment to the end of treatment at 8 weeks | ClinicalTrials.gov | |
| Secondary | Association between faecal VOC features and microbiota composition and diversity (FDR-adjusted) | From enrollment to the end of treatment at 8 weeks | ClinicalTrials.gov | |
| Secondary | Association between faecal VOC features and blood DNA methylation, including interaction with remission/relapse status (FDR-adjusted | From enrollment to the end of treatment at 8 weeks | ClinicalTrials.gov | |
| Secondary | Faecal VOC discrimination of remission versus relapse (cross-validated AUROC, 95% CI) | From enrollment to the end of treatment at 8 weeks | ClinicalTrials.gov | |
| Secondary | Difference in cross-validated AUROC between faecal and urinary VOC models (paired DeLong test) | From enrollment to the end of treatment at 8 weeks | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)