NCT05106075

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2024

Completed
Last Updated

November 3, 2021

Status Verified

October 1, 2021

Enrollment Period

2.5 years

First QC Date

October 8, 2021

Last Update Submit

October 25, 2021

Conditions

Keywords

macrophageinflammationinflammation resolution

Outcome Measures

Primary Outcomes (1)

  • Quantification of cytokine concentrations in samples by ELISA

    up to 2 months

Study Arms (1)

biologic sample collection

EXPERIMENTAL

Blood samples or gingival exsudat collection

Procedure: blood sample or joint fluid or gingival exudate

Interventions

blood sample collected by peripheral blood mobilization joint fluid collected by punction gingival exudate collected with paper strips

biologic sample collection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

Dentist'S Office

Montbéliard, 25200, France

RECRUITING

MeSH Terms

Conditions

Inflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Thomas CHERRIER, MCU-PH

CONTACT

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

Locations