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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 : February 23, 2017
Sponsor:
Collaborator:
Societe Francaise de Rhumatologie
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
The ASSESS national multi-center prospective cohort (Assessment of Systemic complications (Signs) and Evolution in Sjögren's Syndrome "SS") was set up in 2006 thanks to a grant of the French Ministry of Health. Fifteen centers for autoimmune diseases consecutively included consecutive patients with Primary Sjögren's Syndrome "pSS" fulfilling American-European Consensus Criteria (AECG) between 2006 and 2009. The study was approved by the Ethics Committee of Bichat Hospital in 2006. All patients gave their informed written consent. This study was followed for 5 years with the grant of the French Ministry of Health and this study will be extended for 20 years by French Society of Rheumatology (SFR). On an annual basis for a duration of 20 years, a thorough standardized paper case report form (CRF) was filled prospectively by clinicians.

Condition or disease Intervention/treatment
Primary Sjögren's Syndrome Other: No intervention

Detailed Description:

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 395 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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 ]
  3. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
expected population number is 395 patients
Criteria

Inclusion Criteria:

  • aged of 18 years or more
  • Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS

Exclusion Criteria:

  • secondary Sjögren's Syndrome (SJ) associated with other autoimmune diseases
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Xavier Mariette 01.45.21.37.58 xavier.mariette@aphp.fr
Contact: Jacques-Eric Gottenberg 03.88.12.79.50 jacques-Eric.gottenberg@chru-strasbourg.fr

Locations
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France
Hopital Bicêtre Recruiting
Le Kremlin Bicêtre, Val De Marne, France, 94270
Contact: Xavier MARIETTE    01.45.21.37.58    xavier.mariette@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Societe Francaise de Rhumatologie
Investigators
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Principal Investigator: Xavier Mariette SFR/AP-HP
More Information
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Additional Information:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03040583     History of Changes
Other Study ID Numbers: P060228
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Primary Sjögren's syndrome (PSS)
auto-immune diseases
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
 Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases