Pilot Study to Validate ex Vivo Expression of Specific Biomarkers of Human Resolutive Macrophages
RESOMACRO
1 other identifier
interventional
20
1 country
2
Brief Summary
Human resolutive macrophages are essential immune cells in the resolution of inflammation. This particular type of macrophages remains poorly known and currently there are no biomarkers to identify them in vivo. Within UMR1098-RIGHT, specific biomarkers (secreted molecules and membrane receptors) of human resolutive macrophages (healthy volunteers) have been identified in vitro, but their existence in vivo remains an outstanding issue. An exploratory study (lack of data from the literature) will validate the ex vivo expression of these markers in samples of patients whose inflammation is not, or little, supported by the available therapies (NSAIDs, biotherapies, corticosteroids).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2021
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 7, 2021
CompletedFirst Submitted
Initial submission to the registry
October 8, 2021
CompletedFirst Posted
Study publicly available on registry
November 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 7, 2024
CompletedNovember 3, 2021
October 1, 2021
2.5 years
October 8, 2021
October 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quantification of cytokine concentrations in samples by ELISA
up to 2 months
Study Arms (1)
biologic sample collection
EXPERIMENTALBlood samples or gingival exsudat collection
Interventions
blood sample collected by peripheral blood mobilization joint fluid collected by punction gingival exudate collected with paper strips
Eligibility Criteria
You may qualify if:
- Age Limits (18-80 years)
- Information and non-opposition for participating in the study
- Patients suffering from periodontitis grade III ou IV
- Patients suffering from microcristalline arthritis
- patient with health insurance
You may not qualify if:
- patient under corticotherapy
- pregnancy
- non-compliant patient
- patient with no health insurance
- legal incapacity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHRU Besançon
Besançon, 25000, France
Dentist'S Office
Montbéliard, 25200, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- patients are anonymized
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2021
First Posted
November 3, 2021
Study Start
July 7, 2021
Primary Completion
January 7, 2024
Study Completion
January 7, 2024
Last Updated
November 3, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share