<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/NCT04413331</url>
  </required_header>
  <id_info>
    <org_study_id>APHP200109</org_study_id>
    <nct_id>NCT04413331</nct_id>
  </id_info>
  <brief_title>Prospective Longitudinal Cohort Study of Vasculitis Patients</brief_title>
  <acronym>VASCO</acronym>
  <official_title>Cohort Study of Vasculitis Patients: Longitudinal Study for the Assessment of Presentation, Comorbidities, Management, Outcomes and Damage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      VASCO is a prospective observational cohort study which aim to describe the presentation,&#xD;
      comorbidities, management, outcomes and damage of vasculitis patients, from the analysis of&#xD;
      the clinical, biological and immunological data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vasculitis is a group of disorders characterized by the inflammation of blood vessels,&#xD;
      leading to an alteration of the vascular wall. The classification of vasculitides has evolved&#xD;
      considerably over the last few decades.&#xD;
&#xD;
      In 1990, the American College of Rheumatology established a classification of the main&#xD;
      systemic vasculitides based on clinical, biological and histological criteria. In 1994, the&#xD;
      Chapel Hill nomenclature has been established as the reference classification system of&#xD;
      vasculitides and vasculitides were classified according to the size of the affected vessels.&#xD;
      The Chapel Hill nomenclature was revised in 2012, thus enabling to integrate new vasculitides&#xD;
      and diagnostic tools.&#xD;
&#xD;
      It is proposed here to conduct a non-interventional cohort study of the different forms of&#xD;
      vasculitis, as defined in the Chapel Hill nomenclature. By collecting data from a large&#xD;
      number of patients followed prospectively, our objective is to describe the clinical patterns&#xD;
      of these diseases, the presentation, management, comorbidities and outcomes, and to evaluate&#xD;
      their possible association with some immunological, genetic and molecular parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 2, 2020</start_date>
  <completion_date type="Anticipated">July 2030</completion_date>
  <primary_completion_date type="Anticipated">July 2025</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Creation of a prospective cohort of vasculitis</measure>
    <time_frame>5 years</time_frame>
    <description>Vasco cohort : To create of a large prospective cohort of vasculitis patients to describe the presentation, therapeutic management, comorbidities and outcomes, based on the analysis of clinical, biological and immunological data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Creation of a prospective cohort of EGPA-vasculitis</measure>
    <time_frame>5 years</time_frame>
    <description>EGPA -Vasco cohort : To create of a large prospective cohort of vasculitis patients to describe the presentation, therapeutic management and his efficacity, comorbidities and outcomes of EGPA, based on the analysis of clinical, biological and immunological data.&#xD;
The evaluation of the response to the treatment will be based, for all the different treatments, on the ability or not to reach a prednisone dose of 4.0 mg or less, at any time (binary criterion)).&#xD;
The treatments will be used at the discretion of the referring physician in charge of the pathology, according to what is recommended in the National Diagnostic and Care Protocol (PNDS) in force.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification of patterns of vasculitis</measure>
    <time_frame>5 years</time_frame>
    <description>To identify possible relationships between clinical patterns of vasculitis and response to treatment, risk of glucocorticoids dependence, survival, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of comorbidities</measure>
    <time_frame>5 years</time_frame>
    <description>To identify comorbidities and the impact on therapeutic management and patient outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of predictive and prognostic factors</measure>
    <time_frame>5 years</time_frame>
    <description>To identify radiological, histological, pharmacological, genetic, molecular and immunological predictive and prognostic markers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of results reported by patients</measure>
    <time_frame>5 years</time_frame>
    <description>Evaluate the results reported by patients (Patient Reported Outcomes, PROs) within the framework of the Community of Patients for Research (COMPARE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monitoring of the results reported by patients</measure>
    <time_frame>5 years</time_frame>
    <description>Monitor the results reported by patients (Patient Reported Outcomes, PROs) within the framework of the Community of Patients for Research (COMPARE)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">550</enrollment>
  <condition>Vasculitis</condition>
  <arm_group>
    <arm_group_label>Vasculitis</arm_group_label>
    <description>Those with systemic vasculitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EGPA vasculitis</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection</intervention_name>
    <description>Medical data collection at M0, M3, M6, M9 and M12 then every 6 months until M60 and at each vascularitis relapse</description>
    <arm_group_label>EGPA vasculitis</arm_group_label>
    <arm_group_label>Vasculitis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Biological samples and data collection</intervention_name>
    <description>Biological samples at M0, M6, M12, M24 and at each relapse until M60</description>
    <arm_group_label>EGPA vasculitis</arm_group_label>
    <arm_group_label>Vasculitis</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, plasma, Peripheral blood mononuclear cells, DNA, RNA, urin, stools&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The VASCO study population includes adult patients (no age upper-limit) with vasculitis as&#xD;
        defined in the 2012 revised Chapel Hill International Nomenclature, at an active phase of&#xD;
        the disease, either the initial flare or a relapse. Patients will be informed by the study&#xD;
        investigator during a visit as part of their medical follow-up.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (age over 18 years),&#xD;
&#xD;
          -  Patients with vasculitis, as defined in the Chapel Hill International Nomenclature as&#xD;
             revised in 2012,&#xD;
&#xD;
          -  Patients included at an active phase of the disease, either the initial flare or a&#xD;
             relapse,&#xD;
&#xD;
          -  Patients who have been informed and have signed the consent&#xD;
&#xD;
          -  Pregnant and breastfeeding women may be included in the study,&#xD;
&#xD;
          -  Affiliated to a social security system (beneficiary or entitled person).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of consent or inability to obtain consent,&#xD;
&#xD;
          -  A patient who is insane or not entitled, for psychiatric reasons or intellectual&#xD;
             impairment, to receive information about the protocol and to give informed consent,&#xD;
&#xD;
          -  Patient under guardianship / curators&#xD;
&#xD;
          -  Patient on state medical assistance (AME)&#xD;
&#xD;
          -  Hemoglobin less than 7 g/dl at the time of sampling,&#xD;
&#xD;
          -  Hemoglobin level less than 9 g/dl at the time of sampling if the patient has&#xD;
             respiratory or cardiovascular disease,&#xD;
&#xD;
          -  Patient weighs less than 18 kg.&#xD;
&#xD;
          -  Parallel participation in an interventional protocol is permitted.&#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_contact>
    <last_name>Benjamin Terrier, PhD</last_name>
    <phone>+33 1 58 41 14 61</phone>
    <email>benjamin.terrier@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marie BENHAMMANI-GODARD</last_name>
    <phone>00 33 1 54 41 12 11</phone>
    <email>marie.godard@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Service de médecine interne, Hôpital Cochin, AP-HP</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin Terrier, PhD</last_name>
      <phone>+33 1 58 41 14 61</phone>
      <email>benjamin.terrier@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://www.vascularites.org/</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Leavitt RY, Fauci AS, Bloch DA, Michel BA, Hunder GG, Arend WP, Calabrese LH, Fries JF, Lie JT, Lightfoot RW Jr, et al. The American College of Rheumatology 1990 criteria for the classification of Wegener's granulomatosis. Arthritis Rheum. 1990 Aug;33(8):1101-7. doi: 10.1002/art.1780330807.</citation>
    <PMID>2202308</PMID>
  </reference>
  <reference>
    <citation>Lightfoot RW Jr, Michel BA, Bloch DA, Hunder GG, Zvaifler NJ, McShane DJ, Arend WP, Calabrese LH, Leavitt RY, Lie JT, et al. The American College of Rheumatology 1990 criteria for the classification of polyarteritis nodosa. Arthritis Rheum. 1990 Aug;33(8):1088-93. doi: 10.1002/art.1780330805.</citation>
    <PMID>1975174</PMID>
  </reference>
  <reference>
    <citation>Masi AT, Hunder GG, Lie JT, Michel BA, Bloch DA, Arend WP, Calabrese LH, Edworthy SM, Fauci AS, Leavitt RY, et al. The American College of Rheumatology 1990 criteria for the classification of Churg-Strauss syndrome (allergic granulomatosis and angiitis). Arthritis Rheum. 1990 Aug;33(8):1094-100. doi: 10.1002/art.1780330806.</citation>
    <PMID>2202307</PMID>
  </reference>
  <reference>
    <citation>Jennette JC, Falk RJ, Andrassy K, Bacon PA, Churg J, Gross WL, Hagen EC, Hoffman GS, Hunder GG, Kallenberg CG, et al. Nomenclature of systemic vasculitides. Proposal of an international consensus conference. Arthritis Rheum. 1994 Feb;37(2):187-92. doi: 10.1002/art.1780370206.</citation>
    <PMID>8129773</PMID>
  </reference>
  <reference>
    <citation>Jennette JC, Falk RJ, Bacon PA, Basu N, Cid MC, Ferrario F, Flores-Suarez LF, Gross WL, Guillevin L, Hagen EC, Hoffman GS, Jayne DR, Kallenberg CG, Lamprecht P, Langford CA, Luqmani RA, Mahr AD, Matteson EL, Merkel PA, Ozen S, Pusey CD, Rasmussen N, Rees AJ, Scott DG, Specks U, Stone JH, Takahashi K, Watts RA. 2012 revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides. Arthritis Rheum. 2013 Jan;65(1):1-11. doi: 10.1002/art.37715. No abstract available.</citation>
    <PMID>23045170</PMID>
  </reference>
  <reference>
    <citation>van der Woude FJ, Rasmussen N, Lobatto S, Wiik A, Permin H, van Es LA, van der Giessen M, van der Hem GK, The TH. Autoantibodies against neutrophils and monocytes: tool for diagnosis and marker of disease activity in Wegener's granulomatosis. Lancet. 1985 Feb 23;1(8426):425-9. doi: 10.1016/s0140-6736(85)91147-x.</citation>
    <PMID>2857806</PMID>
  </reference>
  <reference>
    <citation>Sable-Fourtassou R, Cohen P, Mahr A, Pagnoux C, Mouthon L, Jayne D, Blockmans D, Cordier JF, Delaval P, Puechal X, Lauque D, Viallard JF, Zoulim A, Guillevin L; French Vasculitis Study Group. Antineutrophil cytoplasmic antibodies and the Churg-Strauss syndrome. Ann Intern Med. 2005 Nov 1;143(9):632-8. doi: 10.7326/0003-4819-143-9-200511010-00006.</citation>
    <PMID>16263885</PMID>
  </reference>
  <reference>
    <citation>Bligny D, Mahr A, Toumelin PL, Mouthon L, Guillevin L. Predicting mortality in systemic Wegener's granulomatosis: a survival analysis based on 93 patients. Arthritis Rheum. 2004 Feb 15;51(1):83-91. doi: 10.1002/art.20082.</citation>
    <PMID>14872460</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>January 24, 2022</last_update_submitted>
  <last_update_submitted_qc>January 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prospective vasculitis cohort</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vasculitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Undecided</ipd_description>
  </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/NCT04413331
org study id: APHP200109
nct id: NCT04413331
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
VASCO is a prospective observational cohort study which aim to describe the presentation,
      comorbidities, management, outcomes and damage of vasculitis patients, from the analysis of
      the clinical, biological and immunological data.
Vasculitis is a group of disorders characterized by the inflammation of blood vessels,
      leading to an alteration of the vascular wall. The classification of vasculitides has evolved
      considerably over the last few decades.

      In 1990, the American College of Rheumatology established a classification of the main
      systemic vasculitides based on clinical, biological and histological criteria. In 1994, the
      Chapel Hill nomenclature has been established as the reference classification system of
      vasculitides and vasculitides were classified according to the size of the affected vessels.
      The Chapel Hill nomenclature was revised in 2012, thus enabling to integrate new vasculitides
      and diagnostic tools.

      It is proposed here to conduct a non-interventional cohort study of the different forms of
      vasculitis, as defined in the Chapel Hill nomenclature. By collecting data from a large
      number of patients followed prospectively, our objective is to describe the clinical patterns
      of these diseases, the presentation, management, comorbidities and outcomes, and to evaluate
      their possible association with some immunological, genetic and molecular parameters.
observational model: Cohort
time perspective: Prospective
measure: Creation of a prospective cohort of vasculitis
time frame: 5 years
description: Vasco cohort : To create of a large prospective cohort of vasculitis patients to describe the presentation, therapeutic management, comorbidities and outcomes, based on the analysis of clinical, biological and immunological data
measure: Creation of a prospective cohort of EGPA-vasculitis
time frame: 5 years
description: EGPA -Vasco cohort : To create of a large prospective cohort of vasculitis patients to describe the presentation, therapeutic management and his efficacity, comorbidities and outcomes of EGPA, based on the analysis of clinical, biological and immunological data.
The evaluation of the response to the treatment will be based, for all the different treatments, on the ability or not to reach a prednisone dose of 4.0 mg or less, at any time (binary criterion)).
The treatments will be used at the discretion of the referring physician in charge of the pathology, according to what is recommended in the National Diagnostic and Care Protocol (PNDS) in force.
measure: Identification of patterns of vasculitis
time frame: 5 years
description: To identify possible relationships between clinical patterns of vasculitis and response to treatment, risk of glucocorticoids dependence, survival, etc.
measure: Identification of comorbidities
time frame: 5 years
description: To identify comorbidities and the impact on therapeutic management and patient outcomes
measure: Identification of predictive and prognostic factors
time frame: 5 years
description: To identify radiological, histological, pharmacological, genetic, molecular and immunological predictive and prognostic markers.
measure: Evaluation of results reported by patients
time frame: 5 years
description: Evaluate the results reported by patients (Patient Reported Outcomes, PROs) within the framework of the Community of Patients for Research (COMPARE)
measure: Monitoring of the results reported by patients
time frame: 5 years
description: Monitor the results reported by patients (Patient Reported Outcomes, PROs) within the framework of the Community of Patients for Research (COMPARE)
arm group label: Vasculitis
description: Those with systemic vasculitis
arm group label: EGPA vasculitis
intervention type: Other
intervention name: Data collection
description: Medical data collection at M0, M3, M6, M9 and M12 then every 6 months until M60 and at each vascularitis relapse
arm group label: EGPA vasculitis
arm group label: Vasculitis
intervention type: Other
intervention name: Biological samples and data collection
description: Biological samples at M0, M6, M12, M24 and at each relapse until M60
arm group label: EGPA vasculitis
arm group label: Vasculitis
Serum, plasma, Peripheral blood mononuclear cells, DNA, RNA, urin, stools
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Terrier, PhD
phone: +33 1 58 41 14 61
email: benjamin.terrier@aphp.fr
last name: Marie BENHAMMANI-GODARD
phone: 00 33 1 54 41 12 11
email: marie.godard@aphp.fr
facility: 
status: Recruiting
contact: 
country: France
url: https://www.vascularites.org/
description: Related Info
citation: Leavitt RY, Fauci AS, Bloch DA, Michel BA, Hunder GG, Arend WP, Calabrese LH, Fries JF, Lie JT, Lightfoot RW Jr, et al. The American College of Rheumatology 1990 criteria for the classification of Wegener's granulomatosis. Arthritis Rheum. 1990 Aug;33(8):1101-7. doi: 10.1002/art.1780330807.
PMID: 2202308
citation: Lightfoot RW Jr, Michel BA, Bloch DA, Hunder GG, Zvaifler NJ, McShane DJ, Arend WP, Calabrese LH, Leavitt RY, Lie JT, et al. The American College of Rheumatology 1990 criteria for the classification of polyarteritis nodosa. Arthritis Rheum. 1990 Aug;33(8):1088-93. doi: 10.1002/art.1780330805.
PMID: 1975174
citation: Masi AT, Hunder GG, Lie JT, Michel BA, Bloch DA, Arend WP, Calabrese LH, Edworthy SM, Fauci AS, Leavitt RY, et al. The American College of Rheumatology 1990 criteria for the classification of Churg-Strauss syndrome (allergic granulomatosis and angiitis). Arthritis Rheum. 1990 Aug;33(8):1094-100. doi: 10.1002/art.1780330806.
PMID: 2202307
citation: Jennette JC, Falk RJ, Andrassy K, Bacon PA, Churg J, Gross WL, Hagen EC, Hoffman GS, Hunder GG, Kallenberg CG, et al. Nomenclature of systemic vasculitides. Proposal of an international consensus conference. Arthritis Rheum. 1994 Feb;37(2):187-92. doi: 10.1002/art.1780370206.
PMID: 8129773
citation: Jennette JC, Falk RJ, Bacon PA, Basu N, Cid MC, Ferrario F, Flores-Suarez LF, Gross WL, Guillevin L, Hagen EC, Hoffman GS, Jayne DR, Kallenberg CG, Lamprecht P, Langford CA, Luqmani RA, Mahr AD, Matteson EL, Merkel PA, Ozen S, Pusey CD, Rasmussen N, Rees AJ, Scott DG, Specks U, Stone JH, Takahashi K, Watts RA. 2012 revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides. Arthritis Rheum. 2013 Jan;65(1):1-11. doi: 10.1002/art.37715. No abstract available.
PMID: 23045170
citation: van der Woude FJ, Rasmussen N, Lobatto S, Wiik A, Permin H, van Es LA, van der Giessen M, van der Hem GK, The TH. Autoantibodies against neutrophils and monocytes: tool for diagnosis and marker of disease activity in Wegener's granulomatosis. Lancet. 1985 Feb 23;1(8426):425-9. doi: 10.1016/s0140-6736(85)91147-x.
PMID: 2857806
citation: Sable-Fourtassou R, Cohen P, Mahr A, Pagnoux C, Mouthon L, Jayne D, Blockmans D, Cordier JF, Delaval P, Puechal X, Lauque D, Viallard JF, Zoulim A, Guillevin L; French Vasculitis Study Group. Antineutrophil cytoplasmic antibodies and the Churg-Strauss syndrome. Ann Intern Med. 2005 Nov 1;143(9):632-8. doi: 10.7326/0003-4819-143-9-200511010-00006.
PMID: 16263885
citation: Bligny D, Mahr A, Toumelin PL, Mouthon L, Guillevin L. Predicting mortality in systemic Wegener's granulomatosis: a survival analysis based on 93 patients. Arthritis Rheum. 2004 Feb 15;51(1):83-91. doi: 10.1002/art.20082.
PMID: 14872460
responsible party type: Sponsor
mesh term: Vasculitis
sharing ipd: Yes
ipd description: Undecided