MoMa Signature During Granulomatosis

Last updated: March 4, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sarcoidosis

Hiv

Lung Disease

Treatment

blood sample

Clinical Study ID

NCT05916638
APHP230273
2022-A02637-36
  • Ages > 18
  • All Genders

Study Summary

Sarcoidosis is a systemic inflammatory disease characterized by unspecific granuloma formation. Our hypothesis is that granuloma formation and maintenance mainly relies on the overactivation of monocytes (Mo) and macrophages (Ma). To this end, the study aims (i) to define MoMa systemic signature in sarcoidosis, (ii) to characterize this signature in situ on tissue samples, and (iii) to identify causative factors that participate to the MoMa chronic overactivation. Thus, a cohort of sarcoidosis patients will be compared with tuberculosis patients. The MoMa systemic signature will be defined on whole blood (TruCulture model) and then in situ through different methods (multi-parameter spectral flow cytometry, RNA-seq, Luminex, imaging mass cytometry). The epigenome of monocytes will be studied thanks to CUT&Tag. The MoMa systemic signature will be defined ex vivo at different time points during the course of the disease with phenotypic, transcriptomic, cytokine and functional approaches. The previously identified signature will be studied in situ and completed by the characterization of granuloma architecture and microenvironmental interactions, which could be modulated by epigenetic modifications. Hence, the epigenome of monocytes will be analyzed in two groups (sarcoidosis and tuberculosis). These results would allow to better understand sarcoidosis physiopathology and, in fine, may raise new therapeutic strategies. Finally, the study could challenge the dogma on innate immunity/auto-inflammation versus adaptive immunity/auto-immunity/memory.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Male and female > 18 years old
  2. Diagnosis of sarcoidosis and of tuberculosis
  3. Affiliated to medical insurance

Exclusion

Exclusion criteria:

  1. HIV infection
  2. pregnant or breastfeeding woman
  3. Patient under legal protection, guardianship or curators
  4. Absence of signed consent"

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: blood sample
Phase:
Study Start date:
January 15, 2024
Estimated Completion Date:
October 31, 2025

Study Description

"Sarcoidosis is an inflammatory disease characterized by the presence of coalescing, tightly clustered, non-necrotizing granulomas. The diagnosis is based on three major criteria: a compatible clinical presentation, the presence of non-necrotizing granulomatous inflammation, and the exclusion of alternative granulomatous diseases. A wide range of clinical phenotypes are observed depending on the location of the granulomatous lesions which can affect any organ, with the lungs being the most affected site. Sarcoidosis shares many similarities with tuberculosis, in which granuloma formation is triggered by Mycobacterium tuberculosis (M. tb). These phenotypic similarities between the two diseases present many challenges for diagnosis, clinical management and therapy.

  Our understanding of the factors that contribute to sarcoidosis development, granuloma
  formation and maintenance remains limited. Part of this challenge is that granuloma
  development may involve both environmental and genetic factors, which contribute to the
  recruitment of immune cells to form the granuloma. Immune cells involved in the granuloma
  include (1) CD4 Th1 and Th17 T cells and their associated cytokines (e.g, IFNγ, TNFα, IL-17,
  IL-2); and (2) monocytes (Mo) and macrophages (Ma) including proinflammatory M1 and
  pro-fibrosis M2 types. However, the specific factors that contribute to granuloma maintenance
  and evolution remain to be identified. Among them, we can hypothesized that trained immunity,
  persistence of the antigen, or the microenvironment are involved in this chronic dysregulated
  immune response. Such an improved understanding of the pathophysiology of the disease may
  allow development of new treatments, as currently corticosteroids remain the mainstay of
  therapy.

  Our main hypothesis is that granuloma formation and maintenance mainly relies on the
  overactivation of monocytes (Mo) and macrophages (Ma). To this end, the study aims (i) to
  define MoMa systemic signature in sarcoidosis, (ii) to characterize this signature in situ on
  tissue samples, and (iii) to identify causative factors that participate to the MoMa chronic
  overactivation. Thus, a cohort of sarcoidosis patients will be compared with tuberculosis
  patients. The MoMa systemic signature will be defined on whole blood (TruCulture model) and
  then in situ through different methods (multi-parameter spectral flow cytometry, RNA-seq,
  Luminex, imaging mass cytometry). The epigenome of monocytes will be studied thanks to
  CUT&Tag. The MoMa systemic signature will be defined ex vivo at different time points (M0, M6
  and M12) during the course of the disease with phenotypic, transcriptomic, cytokine and
  functional approaches. The previously identified signature will be studied in situ and
  completed by the characterization of granuloma architecture and microenvironmental
  interactions, which could be modulated by epigenetic modifications. Hence, the epigenome of
  monocytes will be analyzed in two groups (sarcoidosis and tuberculosis). These results would
  allow to better understand sarcoidosis physiopathology and, in fine, may raise new
  therapeutic strategies. Finally, the study could challenge the dogma on innate
  immunity/auto-inflammation versus adaptive immunity/auto-immunity/memory."
 

Connect with a study center

  • Hôpital Bichat

    Paris, 75018
    France

    Active - Recruiting

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