Pilot Study to Validate ex Vivo Expression of Specific Biomarkers of Human Resolutive Macrophages (RESOMACRO)

October 25, 2021 updated by: Centre Hospitalier Universitaire de Besancon
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besançon, France, 25000
        • Recruiting
        • CHRU Besançon
        • Contact:
          • Daniel Wendling
        • Principal Investigator:
          • Daniel Wendling
      • Montbéliard, France, 25200
        • Recruiting
        • Dentist'S Office
        • Contact:
          • Laure Tisserand
        • Principal Investigator:
          • Laure Tisserand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • patient under corticotherapy
  • pregnancy
  • non-compliant patient
  • patient with no health insurance
  • patient in exclusion period from an other study
  • legal incapacity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: biologic sample collection
Blood samples or gingival exsudat collection
Procedure: blood sample or joint fluid or gingival exudate
blood sample collected by peripheral blood mobilization joint fluid collected by punction gingival exudate collected with paper strips

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantification of cytokine concentrations in samples by ELISA
Time Frame: up to 2 months
up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2021

Primary Completion (Anticipated)

January 7, 2024

Study Completion (Anticipated)

January 7, 2024

Study Registration Dates

First Submitted

October 8, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 3, 2021

Study Record Updates

Last Update Posted (Actual)

November 3, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/562

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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