Clinical trial NCT03765593: Biomarkers in Primary Sjögren's Syndrome
Official title: Gene Expression of Interferon (INF) and B Lymphocyte Biomarkers as Markers of Systemic Affectation and Lymphoproliferative Disease in Primary Sjögren's Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Sjögren Syndrome
Lymphoma, Non-Hodgkin
Keywords: Primary Sjogren Syndrome
Lymphoma
Biomarker
Lead sponsor: National Council of Scientific and Technical Research, Argentina
Sponsor class: OTHER_GOV
First posted: 2018-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with sicca and primary Sjogren Syndrome will be recruited from multiple sites.

Brief summary: 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.

Detailed description: This project, address the value of these proposed biomarkers in pSS with regard to disease activity and risk stratification of pSS subsets. The investigator's group aim to determine if the proposed biomarkers and their gene expression in saliva, peripheral blood and minor salivary gland samples in patients with pSS are increased to know the degree of their usefulness in daily clinical practice, to indicate which patients have a highest risk of developing a hematological malignancy and to know if these biomarkers are useful to recognize patients who have greater activity of the disease to be able to use it in the follow-up of the disease and as a future responder of the new biological therapies against B cells, INF and monocytes.

Gene expression is a highly regulated mechanism that controls the function and adaptability of all living cells. The field of gene expression analysis has undergone important advances in biomedical research. Today, quantification techniques of mRNA expression have led to improvements in the identification of the gene and the sub-classification of the disease, for example, the expression of specific genes (mRNA) can be quantified by reverse transcription and PCR in quantitative real time. This is the most sensitive technique available to detect and quantify mRNA, where extremely small sample sizes can be used in mRNA quantification. Molecular changes precede histological changes and clinicians in the diagnosis of a pathology. For this reason, studying gene expression at the mRNA level allows us to anticipate irreversible changes that take place due to the progress of the pathology in progress.

Eligibility criteria: 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).

Primary outcomes:
measure: Gene expression levels in immune cells in salivary gland biopsy samples from participants with and without pSS
timeFrame: Up to 24 months
measure: Gene expression levels in immune cells in blood samples from participants with and without pSS
timeFrame: Up to 24 months
measure: Gene expression levels in immune cells in saliva samples from participants with and without pSS
timeFrame: Up to 24 months
Secondary outcomes:
measure: Immunoglobulins
timeFrame: Up to 24 months
measure: Complement levels C3 and C4
timeFrame: Up to 24 months
measure: Rheumatoid Factor
timeFrame: Up to 24 months
measure: Cryoglobulins
timeFrame: Up to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: INICSA-Universidad Nacional de Córdoba-CONICET, Córdoba, Argentina
name: Maria Soledad Retamozo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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