NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study
Recruiting · NCT06956703 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Nottingham
View the official record on ClinicalTrials.gov →What this trial is about
The goal of this observational study is to learn about the comparisons of inflammatory markers between IBD and non-IBD (control) participants. The main question it aims to answer is: Are there differences in inflammatory markers between IBD and non-IBD (control) participants.
Who can take part
Age range
16 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- \. Provision of signed and dated, written informed consent before any study specific procedures
- AND
- a. Patients of at least 16 years of age with active Crohn's disease defined as: CRP \> = 5 mg/L OR FCP \> = 250 μg/g OR Visible ulcerations on ileocolonoscopy with a total SES-CD \> = 7, or \> = 4 if disease is confined to the terminal ileum OR visable active disease on cross-sectional imaging. Are switching to a new mechanism of action (MOA) onto anti-TNF therapy or ustekinumab or upadacitinib
- b. Patients of at least 16 years (no upper age limit) with active UC defined as: CRP \> = 5 mg/L OR FCP \> = 250 μg/g OR Mayo endoscopy subscore \> = 2. Are switching to a new mechanism of action (MOA) onto either anti-TNFα therapy or vedolizumab
- c. Non-IBD participants who are attending for a lower GI colonoscopy at any participating site. On any hospital/ medical/ clinical screening list or any other appropriate list with no pathology found on examination.
Exclusion criteria
- Inability to give informed consent
- Any positive result from previous screening for serum hepatitis B surface antigen, hepatitis C or human immunodeficiency virus (HIV)
- An ongoing infection requiring treatment
- Clinical evidence of active COVID infection and/or evidence of active COVID determined by local standard care procedures
- Participation in a clinical study with pharmacological intervention within 3 months prior to Baseline visit.
- Current diagnosis of cancer
- Having received a solid organ or stem cell transplant
- Having received a transfusion of blood, plasma, or platelets within 120 days prior to enrolment
- Confirmed pregnancy at time of enrolment
- For non-IBD participants: A prior history of IBD (CD, UC, microscopic colitis, indeterminate colitis or IBD unspecified)
- Clinical judgement by the investigator that the patient should not participate in the study
- Under 16yrs of age
Where it is running
2 locations listed.
- University of Nottingham - Nottingham, Nottinghamshire, United Kingdom
- University of Nottingham - Nottingham, Nottinghamshire, United Kingdom