Crohn'sUCRecruiting
Evaluation of Molecular Mechanisms of Non-response to Therapy in Patients With Inflammatory Bowel Disease
Not applicable · Testing Samples · 1 site · Central Hospital, Nancy, France
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Samples. Condition(s) listed: Crohn's Disease and Ulcerative Colitis.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Male and female patients ≥ 18 years of age (at the time of signing the Informed Consent)
- Person informed about study organization and having signed the informed consent.
- Established diagnosis of Crohn's dsease or ulcerative colitis with a minimum disease duration of 3 months
Plus 7 more requirement(s). There are also 14 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- Start date: 2023-06-14.
- Main results expected around 2030-08-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- To identify solid biomarkers signatures as well as molecular pathways and mechanisms linked to response and non-response to therapy in ulcerative colitis patient. (week 14)
In the researchers’ words
Inflammatory bowel diseases (IBD) represent a group of immune-mediated disorders, in which currently unidentified trigger factors drive the manifestation of chronic relapsing- remitting destructive inflammatory episodes in the gut. IBD comprise two main disease entities, ulcerati\\ie colitis (UC) and Crohn s disease (CD).
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn's Disease; Ulcerative Colitis |
| Lead sponsor | Central Hospital, Nancy, France |
| Enrollment | 100 (estimated) |
| Start date | 2023-06-14 |
| Primary completion (est.) | 2030-08-01 |
| First posted | 2023-02-17 |
| Last updated | 2025-05-06 |
| Official title | Evaluation of Molecular Mechanisms of Non-response to Treatments, Relapses and Remission in Ulcerative Colitis and Crohn's Disease Patients Receiving First Time Standard of Care Biological Treatment |
| ClinicalTrials.gov ID | NCT05733845 |
Interventions
- Samples (Other)
The intervention is to collect blood; urine; saliva and stool samples but also mucosal biopsies at each protocol visits (baseline and follow up visits).
Full eligibility criteria (from the record)
Inclusion Criteria: * Male and female patients ≥ 18 years of age (at the time of signing the Informed Consent) * Person informed about study organization and having signed the informed consent. * Established diagnosis of Crohn's dsease or ulcerative colitis with a minimum disease duration of 3 months * Moderate to severe disease activity * UC : Mayo Score ≥ 6 including endoscopy score of ≥ 2 * CD : CDAI score betwenn 220 and 450 (inclusive) * Indication to start any biological or small molecule agent (anti-TNF, anti-IL 21/23, anti-integrin and JAK-inhibitors) * In case of treatment with corticosteroid : stable dose for at least 3 weeks prior to baseline, dosage ≤ 20 mg prednisone * Indication for colonoscopy for the assessment of disease activity as for standards of care and current guidelines * Person affiliated to or beneficiary of a social security plan Exclusion Criteria: * Diagnosis of indeterminate colitis, microscopic colitis, ischaemic colitis, infectious colitis, radiation colitis * Absolute contraindications to colonoscopy procedures, complication during previous endoscopy * Bleeding disorders * Indication for surgery for UC * Rectal topical therapy (enemas or suppositories) ≤ 2 weeks prior to baseline * Treatment with > 20 mg prednisone within 3 weeks prior to baseline * Anaemia (haemoglobbin < 10g/dl) at baseline * Subject unable to comply with the study procedures * Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the Public Health Code: * Pregnant, parturient or breastfeeding woman * Minor person (non-emancipated) * Adult person under legal protection (any form of public guardianship) * Adult person incapable of giving consent and not under legal protection * Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| CHRU of Nancy | Vandœuvre-lès-Nancy, CHRU de Nancy | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.