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

Primary Purpose

Inflammation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample or joint fluid or gingival exudate
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation focused on measuring macrophage, inflammation, inflammation resolution

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU BesançonRecruiting
  • Dentist'S OfficeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

biologic sample collection

Arm Description

Blood samples or gingival exsudat collection

Outcomes

Primary Outcome Measures

Quantification of cytokine concentrations in samples by ELISA

Secondary Outcome Measures

Full Information

First Posted
October 8, 2021
Last Updated
October 25, 2021
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT05106075
Brief Title
Pilot Study to Validate ex Vivo Expression of Specific Biomarkers of Human Resolutive Macrophages
Acronym
RESOMACRO
Official Title
Pilot Study to Validate ex Vivo Expression of Specific Biomarkers of Human Resolutive Macrophages
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
January 7, 2024 (Anticipated)
Study Completion Date
January 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
macrophage, inflammation, inflammation resolution

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
patients are anonymized
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
biologic sample collection
Arm Type
Experimental
Arm Description
Blood samples or gingival exsudat collection
Intervention Type
Procedure
Intervention Name(s)
blood sample or joint fluid or gingival exudate
Intervention Description
blood sample collected by peripheral blood mobilization joint fluid collected by punction gingival exudate collected with paper strips
Primary Outcome Measure Information:
Title
Quantification of cytokine concentrations in samples by ELISA
Time Frame
up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas CHERRIER, MCU-PH
Phone
+33(0)768207057
Email
tcherrier@unistra.fr
Facility Information:
Facility Name
CHRU Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Wendling
First Name & Middle Initial & Last Name & Degree
Daniel Wendling
Facility Name
Dentist'S Office
City
Montbéliard
ZIP/Postal Code
25200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure Tisserand
First Name & Middle Initial & Last Name & Degree
Laure Tisserand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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