Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-09-01
2028-11-01
Brief Summary
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* In the main loop, the BMAL1 transcription factor links with CLOCK or NPAS2 ( (Neuronal PAS Domain Protein 2) to activate transcription of per1,2 and 3 and cryptochrome (cry1 and cry2), which in turn repress BMAL1/CLOCK1 transcriptional activity.. The BMAL1/CLOCK complex also activates transcription of numerous target genes (per and cry, Rev-erb, etc.)..
* other secondary loops refine the function of the first.
Recent studies suggest that many aspects of innate immunity are controlled by circadian rhythm through inhibition of NLRP3 inflammasome activation. Nevertheless, the regulation of the NLRP3 inflammasome by the circadian clock has yet to be elucidated. Inflammasomes are molecular platforms that control caspase-1 activation and consequently the maturation of precursors of (interleukine) IL-1β, pro-IL-18, a pro-inflammatory cytokine. Since its discovery, its functions have been widely characterized as part of the innate immune response as a sensor of pathogens and danger signals (extracellular ATP (Adenosine triphosphate), atmospheric pollutants). NLRP3 (nucleotide-binding domain LRR (leucin-rich repeat ) and pyrin-containing receptor 3) has been described for its genetic association with dominant monogenic hereditary syndromes characterized by recurrent systemic inflammatory episodes in the absence of any infection or autoimmune disease, known as CAPS (cryopyrin-associated periodic syndrome) or cryopyrinopathies which is a continuum of diseases ranging from a moderate to the most severe form of the syndrome: familial cold urticaria syndrome, Muckle-Wells syndrome (MWS), and CINCA/NOMID syndrome.
Interestingly, patients with Muckle-Wells syndrome show a circadian pattern of symptoms, with a recurrent, predominantly vesperal fever peak lasting a few hours, and extreme fatigue on a daily basis. However, a molecular link between the circadian clock and CAPS pathology remains to be determined.
The aim of this protocol is to identify circadian rhythm dysregulation in patients with CAPS confirmed by genetic analysis of NLRP3, to demonstrate a link between circadian clock and CAPS syndrome, and to identify circadian clock regulatory pathways.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Patients with cryopyrin-associated periodic syndrome (CAPS)
Confirmed by genetic analysis of NLRP3
Genetic analysis of NLRP3
Blood test for genetic analysis of NLRP3
Circadian rhythm measurement
Wear a Withings Pulse HR (heart rate) actigraphic watch 24 hours a day for 1 month to define circadian rhythm
Saliva sampling
Saliva sampling for salivary melatonin determination
Questionnaire
Questionnaire to determine chronotype
AIDAI score
Disease activity score using AIDAI score (only for patients in the CAPS group) AIDAI : AUTO-INFLAMMATORY DISEASE ACTIVITY INDEX
Blood sampling
1. Inflammatory cytokines measurement : IL1-beta (Interleukin-1) and IL-18.
2. Molecular characterization of circadian clock signaling pathways
Control group
Healthy participant (absence of CAPS, verified by NLRP3 gene analysis) living in the same household as a CAPS participant included in the protocol
Genetic analysis of NLRP3
Blood test for genetic analysis of NLRP3
Circadian rhythm measurement
Wear a Withings Pulse HR (heart rate) actigraphic watch 24 hours a day for 1 month to define circadian rhythm
Saliva sampling
Saliva sampling for salivary melatonin determination
Questionnaire
Questionnaire to determine chronotype
Blood sampling
1. Inflammatory cytokines measurement : IL1-beta (Interleukin-1) and IL-18.
2. Molecular characterization of circadian clock signaling pathways
Interventions
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Genetic analysis of NLRP3
Blood test for genetic analysis of NLRP3
Circadian rhythm measurement
Wear a Withings Pulse HR (heart rate) actigraphic watch 24 hours a day for 1 month to define circadian rhythm
Saliva sampling
Saliva sampling for salivary melatonin determination
Questionnaire
Questionnaire to determine chronotype
AIDAI score
Disease activity score using AIDAI score (only for patients in the CAPS group) AIDAI : AUTO-INFLAMMATORY DISEASE ACTIVITY INDEX
Blood sampling
1. Inflammatory cytokines measurement : IL1-beta (Interleukin-1) and IL-18.
2. Molecular characterization of circadian clock signaling pathways
Eligibility Criteria
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Inclusion Criteria
* Patients aged 6 and over
* Participant with CAPS confirmed by NLRP3 genetic analysis
* Weight greater than or equal to 25 Kg
* Parents/guardians who have been informed of the study and have signed a consent form.
* Patient affiliated to a social security scheme
Control group (healthy participant):
* Participant aged 6 and over
* Weight greater than or equal to 25 Kg
* Participant living in the same household as a subject with CAPS genetically confirmed by NLRP3 analysis and included in the protocol
* Participant with no CAPS (a priori) who consents to NLRP3 genetic analysis
* Parents/guardians who have been informed of the study and have signed a consent form.
* Participant who has been informed of the study and has agreed to take part
* Participant affiliated to a social security scheme
Exclusion Criteria
* Patients with chronic sleep disorders (narcolepsy, hypersomnia) requiring medication (sleeping pills, melatonin).
* Patients with sleep apnea syndrome
* Patients working regular night shifts or alternating day and night shifts
* Pregnant or breast-feeding women
* Parents with an infant under 6 months of age
* Patient participating in another interventional drug study
* Deprivation of civil rights (curators, guardianship, safeguard of justice)
Control group (healthy participant):
* Participants with a chronic illness (ALD beneficiaries)
* Participants with chronic sleep disorders (narcolepsy, hypersomnia) requiring medication (sleeping pills, melatonin)
* Participants working regular night shifts or alternating day and night shifts
* Pregnant or breast-feeding women
* Parents with an infant under 6 months of age
* Participant participating in another interventional drug study
* Deprivation of civil rights (curators, guardianship, safeguard of justice)
6 Years
ALL
Yes
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Hôpital Femme-Mère-Enfant (HCL)
Bron, , France
Hôpital Claude Huriez (CHU de Lille)
Lille, , France
Hôpital de la Croix-Rousse (HCL)
Lyon, , France
Hôpital Edouard Herriot (HCL)
Lyon, , France
Hôpital Tenon (AP-HP)
Paris, , France
Hôpital Kremlin-Bicêtre (AP-HP)
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-A01088-37
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL23_0417
Identifier Type: -
Identifier Source: org_study_id
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