| NCT ID | NCT05916638 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Sarcoidosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-01-15 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 criteria: 1. Male and female \> 18 years old 2. Diagnosis of sarcoidosis and of tuberculosis 3. Affiliated to medical insurance Exclusion criteria: 1. HIV infection 2. pregnant or breastfeeding woman 3. Patient under legal protection, guardianship or curators 4. Absence of signed consent" Secondary exclusion criteria Other causes of granulomatosis ultimately identified as sarcoidosis or tuberculosis
Contact & Investigator
Karim SACRE, MD-PhD, PU-PH
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT05916638 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sarcoidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05916638 currently recruiting?
Yes, NCT05916638 is actively recruiting participants. Contact the research team at karim.sacre@aphp.fr for enrollment information.
Where is the NCT05916638 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05916638 clinical trial?
NCT05916638 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Karim SACRE, MD-PhD, PU-PH at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 100 participants.