<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03040583</url>
  </required_header>
  <id_info>
    <org_study_id>P060228</org_study_id>
    <nct_id>NCT03040583</nct_id>
  </id_info>
  <brief_title>The ASSESS National Multi-center Prospective Cohort</brief_title>
  <acronym>ASSESS</acronym>
  <official_title>Assessment of Systemic Complications (Signs) and Evolution From Patients With Sjögren's Syndrome (ASSESS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Societe Francaise de Rhumatologie</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ASSESS national multi-center prospective cohort (Assessment of Systemic complications&#xD;
      (Signs) and Evolution in Sjögren's Syndrome &quot;SS&quot;) was set up in 2006 thanks to a grant of the&#xD;
      French Ministry of Health. Fifteen centers for autoimmune diseases consecutively included&#xD;
      consecutive patients with Primary Sjögren's Syndrome &quot;pSS&quot; fulfilling American-European&#xD;
      Consensus Criteria (AECG) between 2006 and 2009. The study was approved by the Ethics&#xD;
      Committee of Bichat Hospital in 2006. All patients gave their informed written consent. This&#xD;
      study was followed for 5 years with the grant of the French Ministry of Health and this study&#xD;
      will be extended for 20 years by French Society of Rheumatology (SFR). On an annual basis for&#xD;
      a duration of 20 years, a thorough standardized paper case report form (CRF) was filled&#xD;
      prospectively by clinicians.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Sjögren's syndrome (pSS) affects 0,1% of the population. This systemic autoimmune&#xD;
      disease is characterized by disabling dryness, fatigue and pain, and systemic complications&#xD;
      in 30% of patients. No treatment has proven effective in this disease. The previous or&#xD;
      present systemic complications included skin, articular, lung, kidney, peripheral and central&#xD;
      nervous system, muscular involvement and vasculitis, as well as lymphoma occurrence were&#xD;
      recorded. For previous lymphoma, the diagnosis and the histological subtypes were confirmed&#xD;
      by reanalysis of the medical and histological records. The objective of this cohort was to&#xD;
      assess systemic complications (signs) and evolution of patients with pSS and to determine the&#xD;
      evolution and factors predictors of lymphoma of systemic complications and lymphoma in pSS&#xD;
      during a 20-years prospective follow-up. This cohort was successful in rheumatology field,&#xD;
      395 patients was recruited for 2 years in 15 French centers (10 rheumatology and internal&#xD;
      medicine 5) and followed for 5 years until July 2014.&#xD;
&#xD;
      The primary objective of this cohort is to assess the evolution of Primitive Sjogren Syndrome&#xD;
      patients and to determine predictors factors of lymphoma and systemic complications during a&#xD;
      20-years prospective follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">September 2030</completion_date>
  <primary_completion_date type="Anticipated">September 2030</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>20 Years</target_duration>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>From the beginning of the study until the end of the 20 years follow-up</time_frame>
    <description>To assess the evolution of patients with primary Sjogren's Syndrome, determine the incidence of systemic complications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Variation of complications during the follow-up assessed with ESSDAI activity score and EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) score</measure>
    <time_frame>From the beginning of the study until the end of the 20 years follow-up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>number of patient developing a lymphoma</measure>
    <time_frame>From the beginning of the study until the end of the 20 years follow-up</time_frame>
    <description>To determine the incidence of lymphomas in patients with primary Sjogren's Syndrome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of patients with cancer</measure>
    <time_frame>From the beginning of the study until the end of the 20 years follow-up</time_frame>
    <description>To analysis the incidence of cancer in patients with pSS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients with cardiovascular complication</measure>
    <time_frame>From the beginning of the study until the end of the 20 years follow-up</time_frame>
    <description>To analysis the incidence of cardiovascular complications in patients with pSS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>List of drugs taken by the patients</measure>
    <time_frame>From the beginning of the study until the end of the 20 years follow-up</time_frame>
    <description>To understand better the pathophysiology of the disease (new therapeutic targets for the pathology)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biological report (Blood test)</measure>
    <time_frame>From the beginning of the study until the end of the 20 years follow-up</time_frame>
    <description>To Evaluate the role of biomarkers</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">395</enrollment>
  <condition>Primary Sjögren's Syndrome</condition>
  <arm_group>
    <arm_group_label>ASSESS (PHRC) patients</arm_group_label>
    <description>Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>Patients data will be collected during their disease follow-up</description>
    <arm_group_label>ASSESS (PHRC) patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        expected population number is 395 patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged of 18 years or more&#xD;
&#xD;
          -  Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  secondary Sjögren's Syndrome (SJ) associated with other autoimmune diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xavier Mariette</last_name>
    <role>Principal Investigator</role>
    <affiliation>SFR/AP-HP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xavier Mariette</last_name>
    <phone>01.45.21.37.58</phone>
    <email>xavier.mariette@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jacques-Eric Gottenberg</last_name>
    <phone>03.88.12.79.50</phone>
    <email>jacques-Eric.gottenberg@chru-strasbourg.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hopital Bicêtre</name>
      <address>
        <city>Le Kremlin Bicêtre</city>
        <state>Val De Marne</state>
        <zip>94270</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xavier MARIETTE</last_name>
      <phone>01.45.21.37.58</phone>
      <email>xavier.mariette@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>March 12, 2020</last_update_submitted>
  <last_update_submitted_qc>March 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Primary Sjögren's syndrome (PSS)</keyword>
  <keyword>auto-immune diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sjogren's Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03040583
org study id: P060228
nct id: NCT03040583
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
observational model: Cohort
time perspective: Prospective
measure: 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
description: To assess the evolution of patients with primary Sjogren's Syndrome, determine the incidence of systemic complications
measure: 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
measure: number of patient developing a lymphoma
time frame: From the beginning of the study until the end of the 20 years follow-up
description: To determine the incidence of lymphomas in patients with primary Sjogren's Syndrome
measure: number of patients with cancer
time frame: From the beginning of the study until the end of the 20 years follow-up
description: To analysis the incidence of cancer in patients with pSS.
measure: number of patients with cardiovascular complication
time frame: From the beginning of the study until the end of the 20 years follow-up
description: To analysis the incidence of cardiovascular complications in patients with pSS.
measure: List of drugs taken by the patients
time frame: From the beginning of the study until the end of the 20 years follow-up
description: To understand better the pathophysiology of the disease (new therapeutic targets for the pathology)
measure: Biological report (Blood test)
time frame: From the beginning of the study until the end of the 20 years follow-up
description: To Evaluate the role of biomarkers
arm group label: ASSESS (PHRC) patients
description: Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS
intervention type: Other
intervention name: No intervention
description: Patients data will be collected during their disease follow-up
arm group label: ASSESS (PHRC) patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xavier Mariette
role: Principal Investigator
affiliation: SFR/AP-HP
last name: Xavier Mariette
phone: 01.45.21.37.58
email: xavier.mariette@aphp.fr
last name: Jacques-Eric Gottenberg
phone: 03.88.12.79.50
email: jacques-Eric.gottenberg@chru-strasbourg.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Sjogren's Syndrome
mesh term: Syndrome
sharing ipd: No