Identifying biomarkers for IgG4-related disease
Diagnostic and Prognostic Biomarkers for IgG4-related Disease.
This study is testing new markers in the blood to see if they can help doctors diagnose IgG4-related disease and predict if patients will have a relapse after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05901207 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the validity of diagnostic and prognostic biomarkers for IgG4-related disease through a two-phase approach. Initially, a cross-sectional study will assess the effectiveness of these biomarkers in diagnosing the disease, followed by a prospective cohort study to determine their role in predicting relapse after treatment. The research will be conducted at the Hospital Sant Pau in Barcelona, which specializes in systemic autoimmune diseases and has a dedicated unit for this condition.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years diagnosed with IgG4-related disease according to established criteria.
Not a fit: Patients with cancer, secondary causes of fibrosis, or those who have recently received immunosuppressive treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and better management of IgG4-related disease.
How similar studies have performed: While IgG4-related disease is a relatively new area of study, previous research has indicated potential for success in identifying biomarkers, although this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years of age * Diagnosed of IgG4-related disease (possible, probable or definite) according to the revised Umehara diagnostic criteria Exclusion Criteria: * Patients with cancer * secondary causes of fibrosis * Granulomatosis * Castleman's disease * seropositive Sjögren's syndrome * Primary sclerosing cholangitis. * Patients who have received treatment with prednisone ≥ 5 mg, immunosuppressive or biologic treatment in the last 6 months.
Where this trial is running
Barcelona
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Patricia Moya Alvarado — Sant Pau
- Study coordinator: Patricia Moya Alvarado, Doctor
- Email: pmoyaa@santpau.cat
- Phone: 639196767
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.