Long-term follow-up and biobank for people with systemic granulomatosis
Cohort of Patients With Systemic Granulomatosis (Sarcoidosis and Other Systemic Granulomatoses) and Associated Biological Collection GRAMI-BIO Study
University Hospital, Bordeaux · NCT06854848
This project will follow adults with systemic granulomatosis and collect blood and urine samples to see how the disease progresses and to look for biological markers linked to severity and treatment response.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux (other) |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT06854848 on ClinicalTrials.gov |
What this trial studies
GRAMI-BIO is a prospective single-center cohort at Bordeaux University Hospital that will enroll about 150 adults with histologically proven systemic granulomatosis and follow them for up to ten years (five years of inclusion plus five years of follow-up). At scheduled visits the study will collect blood fractions (serum, plasma), urine, and DNA to create a biological bank for future research. Clinical data on disease course, treatments, and outcomes will be recorded to describe natural history and correlate clinical features with biological markers. Patients with active HIV, HBV, or HCV infection, pregnant or breastfeeding women, and those already on specific granulomatosis treatments are excluded.
Who should consider this trial
Good fit: Adults (18+) with histologically proven systemic granulomatosis who can give informed consent, are affiliated with social security, and are not currently receiving specific treatment for the condition are ideal candidates.
Not a fit: Participants with excluded infections (HIV, HBV, HCV), pregnant or breastfeeding women, people already on specific treatment, or those unable to consent may not benefit from this cohort, and individual participants should not expect direct therapeutic benefit because the project is observational.
Why it matters
Potential benefit: If successful, the biobank and longitudinal data could help identify biomarkers and genetic factors that enable earlier diagnosis, predict disease course, and guide more personalized treatments.
How similar studies have performed: Previous cohort and biobank efforts in sarcoidosis and related granulomatous diseases have identified candidate biomarkers and genetic signals but have not yet produced definitive predictive tests, so this approach is established but still evolving.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 or over * Patients with systemic granulomatosis (diagnosis proven by anatomopathological sampling) at diagnosis. * Persons affiliated to or benefiting from a social security scheme. * Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research). Exclusion Criteria: * Patients infected with human immunodeficiency virus (HIV), Hepatitis B virus (HBV) and/or Hepatitis C virus (HCV) * Pregnant or breast-feeding women * Patients already receiving specific treatment for systemic granulomatosis * Persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent.
Where this trial is running
Bordeaux
- CHU de Bordeaux - service de Médecine Interne et Immunologie Clinique — Bordeaux, France (RECRUITING)
Study contacts
- Principal investigator: Emmanuel RIBEIRO, MD — University Hospital, Bordeaux
- Study coordinator: Emmanuel RIBEIRO, MD
- Email: emmanuel.ribeiro@chu-bordeaux.fr
- Phone: 05.56.79.58.28
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.
Conditions: Granulomatosis, sarcoidosis, Biological collection