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.
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
- Conditions the study is for
- Inflammatory and Non-inflammatory Bone and Joint Diseases
- 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.
France1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| Patients with various bone and joint diseases | Patients 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.
Tissues and biofluid spectra using surface-enhanced Raman spectroscopy
Molecular signature of articular samples
Measured: Inclusion
Protein expression using immunodetection techniques and RNA expression using PCR
Cellular signature of articular samples
Measured: Inclusion
Secondary outcomes (2)
Tissues and biofluid spectra using surface-enhanced Raman spectroscopy
Measured: Inclusion
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.
- First posted15 Mar 2024
- Study start2 Jun 2026
- Primary completionJun 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory and Non-inflammatory Bone and Joint DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Christelle Nguyen, MD, PhD, Principal investigator, Service de Médecine Physique et de Réadaptation, Hôpital Cochin
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Translating Articular Biomarkers Into Diagnoses"
- ClinicalTrials.gov ID
- NCT06312943
- Acronym / sponsor ID
- ARTBioSes / APHP180414
- Keywords
- Osteoarthritis, Rheumatoid arthritis, Inflammatory joint disorders, RAMAN spectroscopy, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with various bone and joint diseases | – | Other: Collection of joint fluid or tissue samplePatients with various bone and joint diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ¨Patients with various bone and joint diseases
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Inability to speak and/or read French
- Neoadjuvant therapy
- Patients under tutor or curatorship
- Protected adults,
- Patients benefiting of State Medical Aid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of joint fluid or tissue sampleDuring 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. | Other | Patients with various bone and joint diseases |
Primary outcome
Tissues and biofluid spectra using surface-enhanced Raman spectroscopy
Time frame: Inclusion
Molecular signature of articular samples
Protein expression using immunodetection techniques and RNA expression using PCR
Time frame: Inclusion
Cellular signature of articular samples
2 secondary outcomes
Tissues and biofluid spectra using surface-enhanced Raman spectroscopy
Time frame: Inclusion
Protein expression using immunodetection techniques and RNA expression using PCR
Time frame: Inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christelle Nguyen, MD, PhD principal investigator
Service de Médecine Physique et de Réadaptation, Hôpital Cochin
1 site in 1 country: see every site and its status.
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.