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Inflammatory and Non-inflammatory Bone and Joint DiseasesARTBioSesNCT06312943

"Translating Articular Biomarkers Into Diagnoses"

An observational study of Inflammatory and Non-inflammatory Bone and Joint Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Early diagnosis is a key factor in the prevention and management of rheumatic diseases. Rheumatic diseases are classically diagnosed based on criteria combining clinical, biological and radiological features. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Collection of joint fluid or tissue sample
How many people
50 participants
Where
1 siteFrance
Study dates
2 Jun 2026to Aug 2029
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: ¨Patients with various bone and joint diseases

Who may be able to join

  • Age ≥ 18 years
  • Inflammatory and non-inflammatory bone and joint diseases requiring synovial fluid aspiration and/or joint replacement
  • Collection of non-opposition
  • Affiliated to or beneficiary of social security

Who cannot join

  • Inability to speak and/or read French
  • Neoadjuvant therapy
  • Patients under tutor or curatorship
  • Protected adults,
  • Patients benefiting of State Medical Aid

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Christelle Nguyen, MD, PhD contact

00 33 1 58 41 29 45

christelle.nguyen2@aphp.fr

Marie Benhammani-Godard contact

00 33 1 58 41 11 90

marie.godard@aphp.fr

France1 site, 1 recruiting
  • Service de Médecine Physique et de Réadaptation, Hôpital Cochin

    Paris, IDF, 75014

    Christelle Nguyen, MD, PhD, 00 33 1 58 41 29 45, christelle.nguyen2@aphp.fr

    François RANNOU, MD, PhD, francois.rannou@aphp.fr

    Recruiting

Other trials in France

About this study

Early diagnosis is a key factor in the prevention and management of rheumatic diseases. Rheumatic diseases are classically diagnosed based on criteria combining clinical, biological and radiological features. However, in up to 20% of the cases, diagnoses remain unstated and underlying rheumatic diseases unclassified, which might lead to delayed specific treatment and unfavourable clinical outcomes. In addition, conventional methods could lack sensitivity and specificity for early diagnosis. Biological samples are attractive targets for the early detection of articular damage because they allow for collection of multiple levels of information from the clinic and the laboratory]. Biological samples most frequently collected from patients with rheumatic diseases are synovial fluid by joint aspiration, blood by venous puncture and tissue specimen by surgery. The investigators hypothesize that in challenging situations, novel biomarkers detected from synovial fluid or articular tissues using both conventional (e.g. histology, immunodetection, PCR) and innovative (e.g. Raman spectroscopy, nanospectroscopy) laboratory tests may help refining diagnosis and better classifying patients with rheumatic diseases.

Read the detailed description

Early diagnosis is a key factor in the prevention and management of rheumatic diseases. Rheumatic diseases are classically diagnosed based on criteria combining clinical, biological and radiological features. However, in up to 20% of the cases, diagnoses remain unstated and underlying rheumatic diseases unclassified, which might lead to delayed specific treatment and unfavourable clinical outcomes. In addition, conventional methods could lack sensitivity and specificity for early diagnosis. Biological samples are attractive targets for the early detection of articular damage because they allow for collection of multiple levels of information from the clinic and the laboratory. Biological samples most frequently collected from patients with rheumatic diseases are synovial fluid by joint aspiration, blood by venous puncture and tissue specimen by surgery. The investigators hypothesize that in challenging situations, novel biomarkers detected from synovial fluid, blood or articular tissues using both conventional (e.g. histology, immunodetection, PCR) and innovative (e.g. Raman spectroscopy, nanospectroscopy) laboratory tests may help refining diagnosis and better classifying patients with rheumatic diseases.

Synovial fluid is primarily composed of water, proteins, proteoglycans, glycosaminoglycans, lipids, small inorganic salts, and metabolites such as amino acids or sugars. Individual synovial fluid components may often perform multiple functions. For example, hyaluronic acid maintains the complex viscoelastic properties of synovial fluids and regulates the biological activity of advanced glycation end-products, cytokines, and enzymes associated with osteoarthritis. Normal joint function is dependent on the status of synovial fluid composition, especially considering the large interaction between the individual components. Although conventional laboratory tests have been used by rheumatologists for the past 50 years, they provide limited quantitative data and cannot specifically describe the biochemical and chemical changes, such as alterations in protein composition and proteomic profile undergone by synovial fluids in arthritic joints. Measurements that reflect the entire synovial fluid chemical, biological or viscoelastic profile could be interesting additional tools. An example of innovative measurement technique is Raman spectroscopy that can be used to detect changes in synovial fluid from patients with rheumatic diseases. Raman band intensity ratios vary significantly in spectra collected from synovial fluid in patients with radiological evidence of osteoarthritis damage. Changes to the protein secondary structure could be used as general marker of chemical changes in synovial fluid and that these changes can be associated with radiographic scoring of knee damage. Other publications focused on the Raman analysis of crystals extracted from synovial fluids. Our group developped Surface Enhanced Raman Spectroscopy (SERS) using nanoparticles that might be more sensitive than conventional Raman spectroscopy in characterizing biofluids especially the entire synovial fluid and deciphering specific rheumatic disease spectral signatures.

Blood biomarkers have long been used for the diagnosis and follow-up of rheumatic diseases. They are mainly markers of auto-immunity, inflammation, cartilage degradation or bone remodelling.

Articular tissues include articular cartilage, bone, meniscus, synovial membrane, fat, tendons, ligaments, muscles. They are obtained during surgery. Their analysis is precious to characterize auto-immunity, inflammation, cartilage degradation or bone remodelling local status and to study local activation of cellular and molecular pathways of interest using conventional techniques of cellular and molecular biology.

Being tested
Collection of joint fluid or tissue sample
Keywords
Osteoarthritis, Rheumatoid arthritis, Inflammatory joint disorders, RAMAN spectroscopy, Biomarkers
Medical subject headings
Joint Diseases, Osteoarthritis, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collection of joint fluid or tissue sampleOther

    During a puncture or joint surgery planned as part of the routine care of the patient, a part of the joint fluid or tissue sample will be collected in order to carry out the analyzes planned for the research.

Study groups in NCT06312943
Study groupRoleWhat they receive
Patients with various bone and joint diseasesPatients with various bone and joint diseases
Receives: Other: Collection of joint fluid or tissue sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tissues and biofluid spectra using surface-enhanced Raman spectroscopy

    Molecular signature of articular samples

    Measured: Inclusion

  2. Protein expression using immunodetection techniques and RNA expression using PCR

    Cellular signature of articular samples

    Measured: Inclusion

Secondary outcomes (2)
  1. Tissues and biofluid spectra using surface-enhanced Raman spectroscopy

    Measured: Inclusion

  2. Protein expression using immunodetection techniques and RNA expression using PCR

    Measured: Inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start2 Jun 2026
  3. Primary completionJun 2029 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06312943
Sponsor's protocol ID
APHP180414
Other IDs
2022-A02170-43
Acronym
ARTBioSes
Status last verified
Jun 2026
First submitted
8 Jan 2024
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory and Non-inflammatory Bone and Joint Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christelle Nguyen, MD, PhD (00 33 1 58 41 29 45, christelle.nguyen2@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tissues and biofluid spectra using surface-enhanced Raman spectroscopy (time frame: Inclusion). The study lists 2 primary outcomes in all. 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 24 Jun 2026.

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