Cohort of Patients With Systemic Granulomatosis and Associated Biological Collection (GRAMI-BIO)

January 30, 2026 updated by: University Hospital, Bordeaux

Cohort of Patients With Systemic Granulomatosis (Sarcoidosis and Other Systemic Granulomatoses) and Associated Biological Collection GRAMI-BIO Study

The GRAMI-BIO study is a prospective single-centre cohort study to recruit 150 patients followed up in the the Bordeaux University Hospital. The total duration of the GRAMI-BIO study is ten years (five years of inclusion with five years of follow-up): Consecutive inclusion of patients meeting the definition of systemic granulomatosis. The main objective of this cohort is to describe to clinical progression of systemic granulomatosis and to collect blood fraction samples (serum bank, plasma bank, urine bank, DNA bank) from subjects participating in the cohort.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Systemic granulomatosis is a group of diseases whose common feature is the anatomopathological existence of giganto-cellular granulomas composed of macrophages, epithelial cells and CD4+ T lymphocytes. The exact cause of the development of these granulomas remains unknown, although numerous studies suggest the hypothesis of environmental factors (infectious, exposure to particles) and genetic susceptibility factors. The persistence of granulomas is deleterious, ultimately leading to local destruction and tissue damage resulting in fibrosis of neighbouring tissues. Granulomatosis is a heterogeneous group in terms of aetiology: schematically, either an aetiology is identified: infection, environmental factors (berylliosis, pneumoconiosis), iatrogenesis (drugs), neoplasia, immune deficiency; or granulomatosis is said to be idiopathic, the most common case, falling within the definition of systemic sarcoidosis. Therefore, with a view to future research work, it seems imperative to set up a biological bank of patients being monitored for systemic granulomatosis within the division. It is particularly important to identify genetic variants, circulating biomarkers associated with the onset, severity and response to treatment of these diseases. The main aim of the "GRAMI-BIO" study is to describe the clinical evolution of patients with systemic granulomatosis (sarcoidosis and other granulomatoses) followed at the Bordeaux University Hospital, and to collect samples from blood fractionation (serum bank, plasma bank, urine bank, DNA, RNA bank) to constitute a biobank.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France
        • Recruiting
        • CHU de Bordeaux - service de Médecine Interne et Immunologie Clinique
        • Sub-Investigator:
          • Camille PROT-LEURENT, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emmanuel RIBEIRO, MD
        • Sub-Investigator:
          • Claire RIVOISY, MD
        • Sub-Investigator:
          • Didier BRONNIMANN, MD
        • Sub-Investigator:
          • Anna MONIER, MD
        • Sub-Investigator:
          • Etienne MERIGLIER, MD
        • Sub-Investigator:
          • Jean-François VIALLARD, Prof
        • Sub-Investigator:
          • Julie MACEY, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients with systemic granulomatosis (diagnosis proven by anatomopathological sampling)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Granulomatosis
Biological: blood sample
30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
Biological: urine sample
10 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Describe the clinical progression of systemic granulomatosis
Time Frame: At baseline (Day 0) and 60 months after baseline
At baseline (Day 0) and 60 months after baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Identify predictive factors for the progression of the disease
Time Frame: At baseline (Day 0) and 60 months after baseline
At baseline (Day 0) and 60 months after baseline
Identify the management methods into patients with systemic granulomatosis
Time Frame: At baseline (Day 0) and 60 months after baseline
At baseline (Day 0) and 60 months after baseline
Identify predictive factors for response to treatments
Time Frame: At baseline (Day 0) and 60 months after baseline
At baseline (Day 0) and 60 months after baseline
Identify new clusters of the disease in a large population both clinically and biologically
Time Frame: At baseline (Day 0) and 60 months after baseline
At baseline (Day 0) and 60 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Emmanuel RIBEIRO, MD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2025

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 3, 2025

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2024/73

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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