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

Sponsoren

Hauptsponsor: National Council of Scientific and Technical Research, Argentina

Quelle National Council of Scientific and Technical Research, Argentina
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Not yet recruiting
Anfangsdatum March 2019
Fertigstellungstermin March 2021
Primäres Abschlussdatum March 2020
Studientyp Observational
Primärer Ausgang
Messen Zeitfenster
Gene expression levels in immune cells in salivary gland biopsy samples from participants with and without pSS Up to 24 months
Gene expression levels in immune cells in blood samples from participants with and without pSS Up to 24 months
Gene expression levels in immune cells in saliva samples from participants with and without pSS Up to 24 months
Sekundäres Ergebnis
Messen Zeitfenster
Immunoglobulins Up to 24 months
Complement levels C3 and C4 Up to 24 months
Rheumatoid Factor Up to 24 months
Cryoglobulins Up to 24 months
Einschreibung 100
Bedingung
Intervention

Interventionsart: Procedure

Interventionsname: Biopsy Salivary Gland

Beschreibung: 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.

Teilnahmeberechtigung

Probenahmeverfahren: Probability Sample

Kriterien:

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).

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Maria Soledad Retamozo, MD, PhD Principal Investigator INICSA-Universidad Nacional de Córdoba-CONICET, Córdoba, Argentina
Gesamtkontakt

Nachname: Maria Soledad Retamozo, MD, PhD

Telefon: 005493516981622

Email: [email protected]

Überprüfungsdatum

December 2018

Verantwortliche Partei

Art: Principal Investigator

Ermittlerzugehörigkeit: National Council of Scientific and Technical Research, Argentina

Vollständiger Name des Ermittlers: Maria Soledad Retamozo

Ermittlertitel: Research Assistant

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Armgruppe

Etikette: Study group 1

Beschreibung: Immunopositive primary SS (Anti-SSA +/anti-Ro+) will receive salivary gland biopsy.

Etikette: Study group 2

Beschreibung: Immunonegative primary SS (Anti-SSA -/anti Ro-, biopsy Chisholm-Mason 3-4) will receive salivary gland biopsy.

Etikette: Study group 3

Beschreibung: Non-autoimmune sicca syndrome (Anti-SSA/anti Ro-, biopsy Chisholm-Mason 2 o less) will receive salivary gland biopsy.

Etikette: Control group

Beschreibung: Patients who have sicca syndrome but do not meet the classification criteria of Sjögren's syndrome, therefore, at the time of evaluating these patients to determine whether or not they have the disease are what will serve as controls since according to the usual diagnostic process, the same studies will be carried out as for patients with the proposed disease. Will receive salivary gland biopsy.

Akronym pSS
Patientendaten No
Studiendesign Info

Beobachtungsmodell: Cohort

Zeitperspektive: Prospective

Quelle: ClinicalTrials.gov