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Identification of Genomic Biomarkers for Rheumatoid Arthritis With Late Onset (BIOGENOPRAT)

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ClinicalTrials.gov Identifier: NCT05808309
Recruitment Status : Not yet recruiting
First Posted : April 11, 2023
Last Update Posted : April 8, 2024
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Sud Francilien

Study Description
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Brief Summary:
Rheumatoid arthritis (RA) is a disabling disease leading to joint and bones destruction. This autoimmune disease is multifactorial, and some genetic and environmental risk factors are already described. However, a part of heritability is still unknown. Previous genomics studies dedicated to deciphering this missing heritability did not pay attention to age of onset. The purpose of this protocol is to determine genomic markers which are specific of RA with an age of onset above 65 years old. Indeed, clinical presentation, treatment tolerance and efficiency, and frequent comorbidities of this phenotype are particular. This signature of genomic biomarkers will be integrated in known molecular pathways to highlight specificities, helpful for biological targets identification.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Other: Salivary sampling

Detailed Description:

The purpose of this protocol is to identify a genomic signature specific of late onset RA and to contribute to the characterization of dedicated therapeutic targets. Collection of patients will be held at the rheumatology service of CHSF (Corbeil-Essonnes, France) and salivary samples will be collected for further genomic analyses conducted by GenHotel lab (Univ Evry - Univ Paris-Saclay, Evry, France).

First, analysis of whole genome/DNA sequences will allow to identify specific variants of late onset RA. Such identified biomarkers would help differential diagnosis and contribute to earlier initiation of care for RA relatives at risk of developing RA. Second, analysis of RNA sequences, including coding protein genes and non-coding RNA, will give information about gene expression and regulation, and molecular pathways. Comparison of patient groups will allow discrimination of biomarkers and molecular signature specific to the disease and to its onset phenotypes. Integration of such genomic data in the RA disease map (consisted of a network of biological pathways), and further modeling approaches, will highlight late onset RA particularities on which research of therapeutic target could be focused on.

To complete genomic analysis, methylome and proteome data will be produced in a second phase. Such data will help in identification of regulation process leading to a protein profile specific of late onset RA.

An ancillary study is planned from familial samples identified after analysis of data collected from RA patients. Risk genetic markers identification is facilitated in a familial context of analyses. Furthermore, non RA individuals in familial sample provide a control sample allowing better discrimination between family-dependent and phenotype-dependent genomic markers

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Genomic Biomarkers for Rheumatoid Arthritis With Late Onset
Estimated Study Start Date : September 1, 2024
Estimated Primary Completion Date : September 1, 2027
Estimated Study Completion Date : September 1, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
PRp
Patients with a diagnostic of rheumatoid arthritis with an age of onset before 60 years
 Other: Salivary sampling
Salivary sampling for genomic material (DNA and RNA (for primary outcome measures); proteins and DNA methylation (for secondary outcome measures)
PRt
Patients with a diagnostic of rheumatoid arthritis with an age of onset from 65 years
 Other: Salivary sampling
Salivary sampling for genomic material (DNA and RNA (for primary outcome measures); proteins and DNA methylation (for secondary outcome measures)
Tem
Patients with a diagnostic of osteoarthritis without RA
 Other: Salivary sampling
Salivary sampling for genomic material (DNA and RNA (for primary outcome measures); proteins and DNA methylation (for secondary outcome measures)
Ap
Relatives to PRt, with RA (with any age of onset) or without RA
 Other: Salivary sampling
Salivary sampling for genomic material (DNA and RNA (for primary outcome measures); proteins and DNA methylation (for secondary outcome measures)


Outcome Measures
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Primary Outcome Measures :
  1. Genomic signature for late onset rheumatoid arthritis [ Time Frame: at day 0 ]
    Genomic DNA analysis

  2. Gene expression for late onset rheumatoid arthritis [ Time Frame: at day 0 ]
    RNA analysis


Secondary Outcome Measures :
  1. Methylome for late onset rheumatoid arthritis [ Time Frame: at day 0 ]
    DNA methylation profile

  2. Proteome for late onset rheumatoid arthritis [ Time Frame: at day 0 ]
    Protein profile


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients followed by the rheumatology service of CHSF
Criteria

Inclusion Criteria:

  • patient with RA diagnosed before 60 years (PRp group)
  • patient with RA diagnosed from 65 years (PRt group)
  • patient without RA followed for osteoarthritis matched with patient of PRt according to age (+/- 1 year) and sex (Tem group).
  • relative of patient PRt, without RA or with RA, regardless of age of onset (Ap group)
  • patient who agreed to participate in the study and signed an informed consent

Exclusion Criteria:

  • other inflammatory and/or autoimmune known disease for patients of PRp and PRt groups
  • first symptoms of osteoarthritis before 40 years, other known inflammatory disease, other known autoimmune disease for Tem group.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05808309


Contacts
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Contact: Pascal HILLIQUIN, MD 01 61 69 31 28 pascal.hilliquin@chsf.fr
Contact: Caroline TOURTE 0161693150 caroline.tourte@chsf.fr

Locations
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France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91106
Contact: Pascal HILLIQUIN, MD    0161693128    pascal.hilliquin@chsf.fr   
Sponsors and Collaborators
Centre Hospitalier Sud Francilien
Investigators
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Study Director: Elisabeth PETIT-TEIXEIRA Laboratoire GenHotel Université d'Evry Val d'Essonne
More Information
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Responsible Party: Centre Hospitalier Sud Francilien
ClinicalTrials.gov Identifier: NCT05808309    
Other Study ID Numbers: 2022/0023
First Posted: April 11, 2023    Key Record Dates
Last Update Posted: April 8, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Sud Francilien:
Late onset rheumatoid arthritis
Genomic biomarkers
Whole genome sequences
 RNAseq
Proteome
Methylome
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases