InflammationRESOMACRONCT05106075
Pilot Study to Validate ex Vivo Expression of Specific Biomarkers of Human Resolutive Macrophages
A study testing blood sample or joint fluid or gingival exudate in people with Inflammation, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inflammation
- What is being tested?
- blood sample or joint fluid or gingival exudate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Jul 2021to 7 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patient under corticotherapy
- pregnancy
- non-compliant patient
- patient with no health insurance
- patient in exclusion period from an other study
- legal incapacity
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHRU Besançon
Besançon, 25000
Daniel Wendling
Daniel Wendling
- Recruiting
Dentist'S Office
Montbéliard, 25200
Laure Tisserand
Laure Tisserand
About this study
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).
- Conditions
- Inflammation
- Being tested
- blood sample or joint fluid or gingival exudate
- Keywords
- macrophage, inflammation, inflammation resolution
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample or joint fluid or gingival exudateProcedure or surgery
blood sample collected by peripheral blood mobilization joint fluid collected by punction gingival exudate collected with paper strips
| Study group | Role | What they receive |
|---|---|---|
| biologic sample collection | Experimental | Blood samples or gingival exsudat collection Receives: Procedure: blood sample or joint fluid or gingival exudate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of cytokine concentrations in samples by ELISA
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start7 Jul 2021
- Primary completion7 Jan 2024 (estimated)
- Study completion7 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106075
- Sponsor's protocol ID
- 2020/562
- Acronym
- RESOMACRO
- Status last verified
- Oct 2021
- First submitted
- 8 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Validate ex Vivo Expression of Specific Biomarkers of Human Resolutive Macrophages
- ClinicalTrials.gov ID
- NCT05106075
- Acronym / sponsor ID
- RESOMACRO / 2020/562
- Conditions
- Inflammation
- Keywords
- macrophage, inflammation, inflammation resolution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 7 Jan 2024 (estimated)
- Study completion
- 7 Jan 2024 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| biologic sample collection | Experimental | Procedure: blood sample or joint fluid or gingival exudateBlood samples or gingival exsudat collection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- patient under corticotherapy
- pregnancy
- non-compliant patient
- patient with no health insurance
- patient in exclusion period from an other study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample or joint fluid or gingival exudateblood sample collected by peripheral blood mobilization joint fluid collected by punction gingival exudate collected with paper strips | Procedure or surgery | biologic sample collection |
Primary outcome
Quantification of cytokine concentrations in samples by ELISA
Time frame: up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample or joint fluid or gingival exudate in people with Inflammation, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas CHERRIER, MCU-PH (+33(0)768207057, tcherrier@unistra.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of cytokine concentrations in samples by ELISA (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021; AzTrials last refreshed its copy on 6 Nov 2026.