Long-term follow-up and biobank for people with systemic granulomatosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.