The ASSESS National Multi-center Prospective Cohort (ASSESS)
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|ClinicalTrials.gov Identifier: NCT03040583|
Recruitment Status : Recruiting
First Posted : February 2, 2017
Last Update Posted : March 13, 2020
|Condition or disease||Intervention/treatment|
|Primary Sjögren's Syndrome||Other: No intervention|
Primary Sjögren's syndrome (pSS) affects 0,1% of the population. This systemic autoimmune disease is characterized by disabling dryness, fatigue and pain, and systemic complications in 30% of patients. No treatment has proven effective in this disease. The previous or present systemic complications included skin, articular, lung, kidney, peripheral and central nervous system, muscular involvement and vasculitis, as well as lymphoma occurrence were recorded. For previous lymphoma, the diagnosis and the histological subtypes were confirmed by reanalysis of the medical and histological records. The objective of this cohort was to assess systemic complications (signs) and evolution of patients with pSS and to determine the evolution and factors predictors of lymphoma of systemic complications and lymphoma in pSS during a 20-years prospective follow-up. This cohort was successful in rheumatology field, 395 patients was recruited for 2 years in 15 French centers (10 rheumatology and internal medicine 5) and followed for 5 years until July 2014.
The primary objective of this cohort is to assess the evolution of Primitive Sjogren Syndrome patients and to determine predictors factors of lymphoma and systemic complications during a 20-years prospective follow-up.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||395 participants|
|Target Follow-Up Duration:||20 Years|
|Official Title:||Assessment of Systemic Complications (Signs) and Evolution From Patients With Sjögren's Syndrome (ASSESS)|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2030|
|Estimated Study Completion Date :||September 2030|
ASSESS (PHRC) patients
Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS
Other: No intervention
Patients data will be collected during their disease follow-up
- Number of patients with systemic complications during the follow-up assessed with European League Against Rheumatism (EULAR) Sjögren Syndrome Disease Activity index (ESSDAI) activity score and ESSPRI score [ Time Frame: From the beginning of the study until the end of the 20 years follow-up ]To assess the evolution of patients with primary Sjogren's Syndrome, determine the incidence of systemic complications
- Variation of complications during the follow-up assessed with ESSDAI activity score and EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) score [ Time Frame: From the beginning of the study until the end of the 20 years follow-up ]
- number of patient developing a lymphoma [ Time Frame: From the beginning of the study until the end of the 20 years follow-up ]To determine the incidence of lymphomas in patients with primary Sjogren's Syndrome
- number of patients with cancer [ Time Frame: From the beginning of the study until the end of the 20 years follow-up ]To analysis the incidence of cancer in patients with pSS.
- number of patients with cardiovascular complication [ Time Frame: From the beginning of the study until the end of the 20 years follow-up ]To analysis the incidence of cardiovascular complications in patients with pSS.
- List of drugs taken by the patients [ Time Frame: From the beginning of the study until the end of the 20 years follow-up ]To understand better the pathophysiology of the disease (new therapeutic targets for the pathology)
- Biological report (Blood test) [ Time Frame: From the beginning of the study until the end of the 20 years follow-up ]To Evaluate the role of biomarkers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040583
|Contact: Xavier Marietteemail@example.com|
|Contact: Jacques-Eric Gottenberg||03.88.12.79.50||jacques-Eric.firstname.lastname@example.org|
|Le Kremlin Bicêtre, Val De Marne, France, 94270|
|Contact: Xavier MARIETTE 01.45.21.37.58 email@example.com|
|Principal Investigator:||Xavier Mariette||SFR/AP-HP|