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Recruiting NCT06854848

Cohort of Patients With Systemic Granulomatosis and Associated Biological Collection

Observational Granulomatosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: blood sample, urine sample.
Who it may be relevant to
Registry conditions: Granulomatosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Biological blood sample
    30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
  • Biological urine sample
    10 ml

Primary outcome measures

  • Describe the clinical progression of systemic granulomatosis [Time frame: At baseline (Day 0) and 60 months after baseline]
Secondary outcome measures (4)
  • Identify predictive factors for the progression of the disease [Time frame: 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]
  • Identify predictive factors for response to treatments [Time frame: 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]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHU de Bordeaux - service de Médecine Interne et Immunologie Clinique — Bordeaux

Identifiers

NCT: NCT06854848 · CHUBX 2024/73

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗