MedTrace Logo

Biomarkers in Primary Sjögren's Syndrome

NCT03765593 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2018-12-05

No results posted yet for this study

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.

Conditions

  • Primary Sjögren Syndrome
  • Lymphoma, Non-Hodgkin

Interventions

PROCEDURE

Biopsy Salivary Gland

A minor salivary gland biopsy will be performed at lower lip, with the minimally invasive technique that is carried out in Rheumatology Unit as a routine procedure for the diagnosis of pSS, from there it will be taken between 2-3 glands for the study. RNAlater®(Ambion, Inc., Texas, United States of America) will be stored in solution for the stabilization and preservation of RNA at -80ºC.

Sponsors & Collaborators

  • National Council of Scientific and Technical Research, Argentina

    lead OTHER_GOV

Principal Investigators

  • Maria Soledad Retamozo, MD, PhD · INICSA-Universidad Nacional de Córdoba-CONICET, Córdoba, Argentina

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-31
Primary Completion
2020-03-31
Completion
2021-03-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03765593 on ClinicalTrials.gov