Clinical trial NCT06854848: Cohort of Patients With Systemic Granulomatosis and Associated Biological Collection
Official title: Cohort of Patients With Systemic Granulomatosis (Sarcoidosis and Other Systemic Granulomatoses) and Associated Biological Collection GRAMI-BIO Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Granulomatosis
Keywords: Granulomatosis
sarcoidosis
Biological collection
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with systemic granulomatosis (diagnosis proven by anatomopathological sampling)

Brief summary: 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.

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.

Primary outcomes:
measure: Describe the clinical progression of systemic granulomatosis
timeFrame: At baseline (Day 0) and 60 months after baseline
Secondary outcomes:
measure: Identify predictive factors for the progression of the disease
timeFrame: At baseline (Day 0) and 60 months after baseline
measure: Identify the management methods into patients with systemic granulomatosis
timeFrame: At baseline (Day 0) and 60 months after baseline
measure: Identify predictive factors for response to treatments
timeFrame: At baseline (Day 0) and 60 months after baseline
measure: Identify new clusters of the disease in a large population both clinically and biologically
timeFrame: At baseline (Day 0) and 60 months after baseline
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - service de Médecine Interne et Immunologie Clinique
Study officials:
affiliation: University Hospital, Bordeaux
name: Emmanuel RIBEIRO, MD
role: PRINCIPAL_INVESTIGATOR
References: