Clinical trial · Observational
Biomarkers in Primary Sjögren's Syndrome
Gene Expression of Interferon (INF) and B Lymphocyte Biomarkers as Markers of Systemic Affectation and Lymphoproliferative Disease in Primary Sjögren's Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The clinical spectrum of primary Sjogren Syndrome (pSS)ranges from sicca syndrome to systemic involvement (extraglandular manifestations), including a large number of manifestations that may be the form of presentation or appear after the disease is diagnosed, and that clearly mark the prognosis of the disease. Gene expression levels of Interferon (INF) and B Lymphocyte Biomarkers as Markers of Systemic Affectation and Lymphoproliferative Disease in, together with clinical and laboratory parameters, will provide significant information about the risk of developing hematological neoplasms in patients with pSS at different stages of the disease, and lead to better management of the disease treatment and therapeutic behaviors. Using the proposed technique allows us to study the gene expression at the mRNA level of each biomarker, which allows us to anticipate the irreversible changes that take place due to the progress of the pathology in progress, since the molecular changes precede the histological changes and in the pathological diagnosis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Primary Sjögren Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy Salivary Gland | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Study group 1
- description
- Immunopositive primary SS (Anti-SSA +/anti-Ro+) will receive salivary gland biopsy.
- interventionNames
- Procedure: Biopsy Salivary Gland
- label
- Study group 2
- description
- Immunonegative primary SS (Anti-SSA -/anti Ro-, biopsy Chisholm-Mason 3-4) will receive salivary gland biopsy.
- interventionNames
- Procedure: Biopsy Salivary Gland
- label
- Study group 3
- description
- Non-autoimmune sicca syndrome (Anti-SSA/anti Ro-, biopsy Chisholm-Mason 2 o less) will receive salivary gland biopsy.
- interventionNames
- Procedure: Biopsy Salivary Gland
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients: cross sectionally patients will be included for clinical suspicion of primary SS or with the diagnosis already established in Rheumatology unit. The following inclusion criteria will be applied to the study: * Age \> 18 years * Informed consent of the patient. Exclusion Criteria: * Impossibility of obtaining consent (cognitive impairment, other causes). * Associated systemic autoimmune or rheumatological diseases. * Chronic viral infections (HCV, HBV, HIV).
References
Publications (22)
- BACKGROUNDRetamozo S, Flores-Chavez A, Consuegra-Fernandez M, Lozano F, Ramos-Casals M, Brito-Zeron P. Cytokines as therapeutic targets in primary Sjogren syndrome. Pharmacol Ther. 2018 Apr;184:81-97. doi: 10.1016/j.pharmthera.2017.10.019. Epub 2017 Oct 29. PMID 29092775
- BACKGROUNDKassan SS, Thomas TL, Moutsopoulos HM, Hoover R, Kimberly RP, Budman DR, Costa J, Decker JL, Chused TM. Increased risk of lymphoma in sicca syndrome. Ann Intern Med. 1978 Dec;89(6):888-92. doi: 10.7326/0003-4819-89-6-888. PMID 102228
- BACKGROUNDJonsson R, Gordon TP, Konttinen YT. Recent advances in understanding molecular mechanisms in the pathogenesis and antibody profile of Sjogren's syndrome. Curr Rheumatol Rep. 2003 Aug;5(4):311-6. doi: 10.1007/s11926-003-0010-z. PMID 14531959
- BACKGROUNDIoannidis JP, Vassiliou VA, Moutsopoulos HM. Long-term risk of mortality and lymphoproliferative disease and predictive classification of primary Sjogren's syndrome. Arthritis Rheum. 2002 Mar;46(3):741-7. doi: 10.1002/art.10221. PMID 11920410
- BACKGROUNDBrito-Zeron P, Retamozo S, Gheitasi H, Ramos-Casals M. Erratum to: Treating the Underlying Pathophysiology of Primary Sjogren Syndrome: Recent Advances and Future Prospects. Drugs. 2016 Dec;76(18):1799. doi: 10.1007/s40265-016-0669-x. No abstract available. PMID 27905085
- BACKGROUNDRose T, Grutzkau A, Hirseland H, Huscher D, Dahnrich C, Dzionek A, Ozimkowski T, Schlumberger W, Enghard P, Radbruch A, Riemekasten G, Burmester GR, Hiepe F, Biesen R. IFNalpha and its response proteins, IP-10 and SIGLEC-1, are biomarkers of disease activity in systemic lupus erythematosus. Ann Rheum Dis. 2013 Oct;72(10):1639-45. doi: 10.1136/annrheumdis-2012-201586. Epub 2012 Oct 31. PMID 23117242
- RESULTMartin T, Weber JC, Levallois H, Labouret N, Soley A, Koenig S, Korganow AS, Pasquali JL. Salivary gland lymphomas in patients with Sjogren's syndrome may frequently develop from rheumatoid factor B cells. Arthritis Rheum. 2000 Apr;43(4):908-16. doi: 10.1002/1529-0131(200004)43:43.0.CO;2-K.