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NCT Number: NCT06854848

Cohort of Patients With Systemic Granulomatosis and Associated Biological Collection

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux - service de Médecine Interne et Immunologie Clinique

Bordeaux, France

Location status: Recruiting

Location contact

Anna MONIER, MD

SUB_INVESTIGATOR

Camille PROT-LEURENT, MD

SUB_INVESTIGATOR

Claire RIVOISY, MD

SUB_INVESTIGATOR

Didier BRONNIMANN, MD

SUB_INVESTIGATOR

Emmanuel RIBEIRO, MD

CONTACT

[email protected]

05.56.79.58.28 ext. +33

Emmanuel RIBEIRO, MD

PRINCIPAL_INVESTIGATOR

Etienne MERIGLIER, MD

SUB_INVESTIGATOR

Jean DELAUNE

CONTACT

[email protected]

Jean-François VIALLARD, Prof

SUB_INVESTIGATOR

Julie MACEY, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sample

Biological

30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

urine sample

Biological

10 ml

Primary outcomes

  1. Describe the clinical progression of systemic granulomatosis

    Time frame: At baseline (Day 0) and 60 months after baseline

Secondary outcomes

  1. Identify predictive factors for the progression of the disease

    Time frame: At baseline (Day 0) and 60 months after baseline

  2. Identify the management methods into patients with systemic granulomatosis

    Time frame: At baseline (Day 0) and 60 months after baseline

  3. Identify predictive factors for response to treatments

    Time frame: At baseline (Day 0) and 60 months after baseline

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuel RIBEIRO, MD

CONTACT

[email protected]

05.56.79.58.28 ext. +33

Jean DELAUNE

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: GRAMI-BIO

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Mar 3, 2025
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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