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临床试验/NCT03765593
NCT03765593Unknown不适用

Gene Expression of Interferon (INF) and B Lymphocyte Biomarkers as Markers of Systemic Affectation and Lymphoproliferative Disease in Primary Sjögren's Syndrome

National Council of Scientific and Technical Research, Argentina0 个研究点目标入组 100 人开始时间: 2019年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Gene expression levels in immune cells in salivary gland biopsy samples from participants with and without pSS

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Impossibility of obtaining consent (cognitive impairment, other causes).
  • Associated systemic autoimmune or rheumatological diseases.
  • Chronic viral infections (HCV, HBV, HIV).

结局指标

主要结局

Gene expression levels in immune cells in salivary gland biopsy samples from participants with and without pSS

时间窗: Up to 24 months

To identify a biomarker of disease activity, measured by the real-time PCR reactions (qRT-PCR).

Gene expression levels in immune cells in blood samples from participants with and without pSS

时间窗: Up to 24 months

To identify a biomarker of disease activity, measured by the real-time PCR reactions (qRT-PCR).

Gene expression levels in immune cells in saliva samples from participants with and without pSS

时间窗: Up to 24 months

To identify a biomarker of disease activity, measured by the real-time PCR reactions (qRT-PCR).

次要结局

  • Immunoglobulins(Up to 24 months)
  • Cryoglobulins(Up to 24 months)
  • Complement levels C3 and C4(Up to 24 months)
  • Rheumatoid Factor(Up to 24 months)

研究者

发起方
National Council of Scientific and Technical Research, Argentina
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Maria Soledad Retamozo

Research Assistant

National Council of Scientific and Technical Research, Argentina

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