Evaluating biomarkers in patients with moderate to severe ulcerative colitis receiving targeted therapies
A Multicentre Prospective Longitudinal Observational Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis (UC) Patients Treated With Different Targeted Therapies
This study is trying to find specific markers in blood, stool, and tissue that can help doctors choose the best targeted treatments for people with moderate to severe ulcerative colitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 95 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Drugs / interventions | radiation, prednisone |
| Locations | 1 site (Nancy, Lorraine) |
| Trial ID | NCT05456893 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify biomarkers in blood, stool, and tissue that can predict the response to various targeted therapies in patients with moderate to severe ulcerative colitis. By understanding these biomarkers, the study seeks to enhance personalized medicine approaches, ensuring that patients receive the most effective treatment based on their individual profiles. The study will involve procedures such as endoscopic biopsies, blood sampling, and stool sampling to gather necessary data. The ultimate goal is to improve treatment outcomes for patients suffering from this chronic inflammatory bowel disease.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of moderate to severe ulcerative colitis.
Not a fit: Patients with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or radiation colitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with ulcerative colitis.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for inflammatory bowel diseases, suggesting that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female patients ≥ 18 years of age (at the time of signing the ICF) * Established diagnosis of ulcerative colitis with a minimum disease duration of 3 months * Moderate to severe active UC defined by Mayo Score ≥ 6 * Moderate to severe active UC defined by endoscopy score of ≥2 * Indication to start any biological or small molecule agent (anti-TNF, anti- IL12/23, 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 an endoscopy for the assessment of disease activity as for standards of care and current guidelines * Able to comply with the study procedures * Person affiliated to or beneficiary of a social security plan * Person informed about study organization and able to sign informed consent form Exclusion Criteria: * Diagnosis of indeterminate colitis, microscopic colitis, ischaemic colitis, infectious colitis, radiation colitis * Absolute contraindications to endoscopy procedures or 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 (haemoglobin \< 10 g/dl) at baseline * Any circumstances which could contradict a study participation and lead the Investigator to assess the patient as unsuitable for study participation for any other reason * 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
Where this trial is running
Nancy, Lorraine
- Central Hospital — Nancy, Lorraine, France (Recruiting)
Study contacts
- Study coordinator: Laurent MD Peyrin-Biroulet, PhD
- Email: peyrinbiroulet@gmail.com
- Phone: 0383153661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.