Sjogren's SyndromeTOCOSSNCT06454370
Histopathological Analysis Versus Full-field Optical Coherence Tomography of Minor Salivary Gland Biopsy in Suspect Sjogren Syndrome
An observational study of Sjogren's Syndrome and Tomography Optical Coherence, run by Centre Hospitalier de Mâcon at 1 site in France.
Trial summary
Primary Sjögren syndrome (pSS) is a systemic autoimmune disease that mainly affects the exocrine glands leading to severe dryness of mucosal surfaces, principally in the mouth and eyes. The other clinical manifestations are fatigue and musculoskeletal pain. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sjogren's Syndrome, Tomography Optical Coherence
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2024to 7 Dec 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: TOCOSS cohort : Patient > 18 years old with suspected Sjogren Syndrome received minor gland salivary biopsy
Who may be able to join
- Patient > 18 years of age with suspected Sjogren Syndrome received minor gland salivary biopsy
Who cannot join
- Inability to perform dynamic full-field optical coherence tomography observation at the moment of temporal artery biopsy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Mâcon
Mâcon, Sâone-et-Loire, 71000
Thibault MAILLET, +33 3 85 27 73 43, thmaillet@ch-macon.fr
About this study
Official title: Histopathological Analysis of Minor Salivary Gland Biopsy Following Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings in Patients Suspect Sjogren Syndrome.
Primary Sjögren syndrome (pSS) is a systemic autoimmune disease that mainly affects the exocrine glands leading to severe dryness of mucosal surfaces, principally in the mouth and eyes. The other clinical manifestations are fatigue and musculoskeletal pain. Diagnosis of pSS associates clinical abnormalities with specific antibodies (Ro/SSA and La/SSB antibodies) or histopathological criteria of a minor salivary gland biopsy (the presence and number of lymphocytic focus, as well as chronicity findings like acinar atrophy, ductal dilatation or fibrosis). Apart from its variable sensitivity, one of the weaknesses of minor salivary gland biopsy is the delay in obtaining the result due to the time required to prepare the sample for histological analysis.
Our group recently demonstrated the use of full-field optical coherence tomography (FF-OCT) to visualize structural changes associated with the inflammatory processes in Giant Cell Arteritis (temporal artery biopsy examination). It may suggests a further use of dynamic FF-OCT of minor salivary gland biopsy to visualize structural changes associated with the lymhocytic focus to ensure rapid on-site diagnosis of pSS.
Read the detailed description
This study does not require additional examination, and will use the data performed from the minor salivary gland biopsy carried out as part of usual care, in comparison with the results of the conventional histopathological examination.
- Conditions
- Sjogren's Syndrome, Tomography Optical Coherence
- Keywords
- Minor Salivary gland biopsy, Tomography, Optical Coherence
- Medical subject headings
- Sjogren's Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathological analysis of healthy minor salivary gland biopsy with dynamic full-field optical coherence tomography
Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify the normal structures of a minor salivary gland biopsy, i.e . salivary parenchyma with secretory units arranged into acini (group of acinar cells organized around a narrow lumen)
Measured: Outcome measure is assessed 15 days following minor salivary gland biopsy
Secondary outcomes (1)
Histopathological analysis of Sjogren's syndrom minor salivary gland biopsy with dynamic full-field optical coherence tomography
Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify histopathological features of Sjogren syndrom, i.e. lymphocytic foci, particularly located in the periductal area (according to the classification defined by Chisholm and Mason), acinar atrophy, ductal dilatation, and fibrosis
Measured: Outcome measure is assessed 15 days following minor salivary gland biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start7 Jun 2024
- Primary completion7 Oct 2024 (estimated)
- Study completion7 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Mâcon
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier William Morey - Chalon sur Saône, Centre Hospitalier Universitaire Dijon
- Responsible party
- Sponsor
- Investigators
- Thibault MAILLET, Principal investigator, Internal Medicine - Centre Hospitalier de Mâcon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454370
- Sponsor's protocol ID
- TOCOSS
- Acronym
- TOCOSS
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manuel RC, Pilar BZ, Raphaele S, Hendrika B, Simon J B, Thomas D, Jacques-Eric G, Xavier M, Elke T, Stefano B, Salvatore V, Thomas M, Wan-Fai N, Aike K, Athanasios T, Claudio V; EULAR Sjogren Syndrome Task Force. Characterization of systemic disease in primary Sjogren's syndrome: EULAR-SS Task Force recommendations for articular, cutaneous, pulmonary and renal involvements. Rheumatology (Oxford). 2017 Jul 1;56(7):1245. doi: 10.1093/rheumatology/kex157. No abstract available.
PubMed 28379527Shiboski CH, Shiboski SC, Seror R, Criswell LA, Labetoulle M, Lietman TM, Rasmussen A, Scofield H, Vitali C, Bowman SJ, Mariette X; International Sjogren's Syndrome Criteria Working Group. 2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts. Arthritis Rheumatol. 2017 Jan;69(1):35-45. doi: 10.1002/art.39859. Epub 2016 Oct 26.
PubMed 27785888Maldiney T, Greigert H, Martin L, Benoit E, Creuzot-Garcher C, Gabrielle PH, Chassot JM, Boccara C, Balvay D, Tavitian B, Clement O, Audia S, Bonnotte B, Samson M. Full-field optical coherence tomography for the diagnosis of giant cell arteritis. PLoS One. 2020 Aug 31;15(8):e0234165. doi: 10.1371/journal.pone.0234165. eCollection 2020.
PubMed 32866179
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histopathological Analysis of Minor Salivary Gland Biopsy Following Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings in Patients Suspect Sjogren Syndrome.
- ClinicalTrials.gov ID
- NCT06454370
- Acronym / sponsor ID
- TOCOSS / TOCOSS
- Conditions
- Sjogren's Syndrome, Tomography Optical Coherence
- Keywords
- Minor Salivary gland biopsy, Tomography, Optical Coherence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier de MâconUniversity, hospital or other
- Collaborators
- Centre Hospitalier William Morey - Chalon sur Saône, Centre Hospitalier Universitaire Dijon
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 7 Oct 2024 (estimated)
- Study completion
- 7 Dec 2024 (estimated)
- First posted
- 12 Jun 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.
Primary Sjögren syndrome (pSS) is a systemic autoimmune disease that mainly affects the exocrine glands leading to severe dryness of mucosal surfaces, principally in the mouth and eyes. The other clinical manifestations are fatigue and musculoskeletal pain. Diagnosis of pSS associates clinical abnormalities with specific antibodies (Ro/SSA and La/SSB antibodies) or histopathological criteria of a minor salivary gland biopsy (the presence and number of lymphocytic focus, as well as chronicity findings like acinar atrophy, ductal dilatation or fibrosis). Apart from its variable sensitivity, one of the weaknesses of minor salivary gland biopsy is the delay in obtaining the result due to the time required to prepare the sample for histological analysis.
Our group recently demonstrated the use of full-field optical coherence tomography (FF-OCT) to visualize structural changes associated with the inflammatory processes in Giant Cell Arteritis (temporal artery biopsy examination). It may suggests a further use of dynamic FF-OCT of minor salivary gland biopsy to visualize structural changes associated with the lymhocytic focus to ensure rapid on-site diagnosis of pSS.
Detailed description
This study does not require additional examination, and will use the data performed from the minor salivary gland biopsy carried out as part of usual care, in comparison with the results of the conventional histopathological examination.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- TOCOSS cohort : Patient > 18 years old with suspected Sjogren Syndrome received minor gland salivary biopsy
Key inclusion criteria (1 listed)
- Patient > 18 years of age with suspected Sjogren Syndrome received minor gland salivary biopsy
Key exclusion criteria (1 listed)
- Inability to perform dynamic full-field optical coherence tomography observation at the moment of temporal artery biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Histopathological analysis of healthy minor salivary gland biopsy with dynamic full-field optical coherence tomography
Time frame: Outcome measure is assessed 15 days following minor salivary gland biopsy
Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify the normal structures of a minor salivary gland biopsy, i.e . salivary parenchyma with secretory units arranged into acini (group of acinar cells organized around a narrow lumen)
1 secondary outcome
Histopathological analysis of Sjogren's syndrom minor salivary gland biopsy with dynamic full-field optical coherence tomography
Time frame: Outcome measure is assessed 15 days following minor salivary gland biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Results publication: PubMed 28379527Manuel RC, Pilar BZ, Raphaele S, Hendrika B, Simon J B, Thomas D, Jacques-Eric G, Xavier M, Elke T, Stefano B, Salvatore V, Thomas M, Wan-Fai N, Aike K, Athanasios T, Claudio V; EULAR Sjogren Syndrome Task Force. Characterization of systemic disease in primary Sjogren's syndrome: EULAR-SS Task Force recommendations for articular, cutaneous, pulmonary and renal involvements. Rheumatology (Oxford). 2017 Jul 1;56(7):1245. doi: 10.1093/rheumatology/kex157. No abstract available.
- Results publication: PubMed 27785888Shiboski CH, Shiboski SC, Seror R, Criswell LA, Labetoulle M, Lietman TM, Rasmussen A, Scofield H, Vitali C, Bowman SJ, Mariette X; International Sjogren's Syndrome Criteria Working Group. 2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts. Arthritis Rheumatol. 2017 Jan;69(1):35-45. doi: 10.1002/art.39859. Epub 2016 Oct 26.
- Results publication: PubMed 32866179Maldiney T, Greigert H, Martin L, Benoit E, Creuzot-Garcher C, Gabrielle PH, Chassot JM, Boccara C, Balvay D, Tavitian B, Clement O, Audia S, Bonnotte B, Samson M. Full-field optical coherence tomography for the diagnosis of giant cell arteritis. PLoS One. 2020 Aug 31;15(8):e0234165. doi: 10.1371/journal.pone.0234165. eCollection 2020.
- Individual participant dataSharing planned: No
Related trials for Sjogren's Syndrome
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Recruiting
Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
Sjögren's Syndrome, Small Fiber Neuropathy
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. This study is not recruiting at the moment.
Thibault MAILLET principal investigator
Internal Medicine - Centre Hospitalier de Mâcon
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 Sjogren's Syndrome and Tomography Optical Coherence, run by Centre Hospitalier de Mâcon 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thibault MAILLET (+33 3 85 27 73 43, thmaillet@ch-macon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histopathological analysis of healthy minor salivary gland biopsy with dynamic full-field optical coherence tomography (time frame: Outcome measure is assessed 15 days following minor salivary gland biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06454370, which also lists 3 linked publications.
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 12 Jun 2024.