<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/NCT03270358</url>
  </required_header>
  <id_info>
    <org_study_id>17-AOI-03</org_study_id>
    <nct_id>NCT03270358</nct_id>
  </id_info>
  <brief_title>OStéopontin as a Marker Of StenoSIS - OSMOSIS</brief_title>
  <acronym>OSMOSIS</acronym>
  <official_title>OStéopontin as a Marker Of StenoSIS - OSMOSIS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</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>
      Our hypothesis is that a plasma protein named osteopontin (OPN) could serve as a biological&#xD;
      predictive marker of acute AVF dysfunction. In several scientific studies, plasma OPN was&#xD;
      correlated with coronary stent restenosis, and with cardiovascular outcome in patients with&#xD;
      diabetes and renal insufficiency. This protein is secreted by several cellular types, like&#xD;
      distal tubule epithelial cells, macrophages, but also fibroblasts and cardiac and vascular&#xD;
      endothelial cells, in response to several specific stimuli. It acts like a cytokine, inducing&#xD;
      immunological mechanisms as well as tissue remodeling.&#xD;
&#xD;
      The main objective of this study is to show that the amount of plasma OPN is higher in&#xD;
      patients presenting with an AVF stenosis, compared with patients with a functioning AVF.&#xD;
&#xD;
      OSMOSIS is a monocentric pilot study that will include patients into two groups during 12&#xD;
      months (no specific follow-up). The control group will include patients that have been&#xD;
      dialyzed on an AVF, in the dialysis center of Nice University Hospital, for at least 3 months&#xD;
      without any incident. The experimental group will include hemodialysis patients hospitalized&#xD;
      in the department of vascular surgery for acute AVF dysfunction, needing endovascular or open&#xD;
      surgical revision for venous stenosis.&#xD;
&#xD;
      Blood will be withdrawn right before dialysis or surgical procedure. Plasma OPN will me&#xD;
      measured by ELISA. Their clinical data would be collected from medical file at the same time.&#xD;
      After the procedure, patients will be followed-up according to usual protocols.&#xD;
&#xD;
      To show a significant difference of 100ng/mL plasma OPN between the two groups, with a power&#xD;
      of 90% and alpha risk of 0.05, we plan to include 76 patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 12, 2017</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasmatic osteopontin level</measure>
    <time_frame>at inclusion</time_frame>
    <description>Plasmatic osteopontin level (ng/ml) collected in the patient's arteriovenous fistula.&#xD;
Control arm: right before a dialysis session&#xD;
Experimental arm: right before the surgery for stenosis of the fistula</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peripheral plasmatic osteopontin level in the contralateral arm</measure>
    <time_frame>at inclusion</time_frame>
    <description>Peripheral plasmatic osteopontin level (ng/ml) collected in the contralateral arm (to measure the potential bias of a local osteopontin production in the fistula)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral plasmatic osteopontin level in the contralateral arm</measure>
    <time_frame>at inclusion</time_frame>
    <description>Measure of the plasmatic osteopontin specificity and sensibility on the occurrence of a fistula stenosis (differents tresholds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral plasmatic osteopontin level in the contralateral arm</measure>
    <time_frame>at inclusion</time_frame>
    <description>Collection of comorbidity factors (diabetes, arterial hypertension, coronaropathy, overweight (BMI)), clinical factors (age and gender) and treatments at the time of patient's inclusion (anticoagulant, antisludge, antihypertensive drug, statins, erythropoietin)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">76</enrollment>
  <condition>Stenosis</condition>
  <arm_group>
    <arm_group_label>patient with stenosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient coming to the vascular surgery unit to receive surgery regarding their fistula stenosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patient without stenosis</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patient coming for their dialysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood sampling in arterioveinous fistula without stenosis</intervention_name>
    <description>Plasmatic osteopontin level (ng/ml) collected in the patient's arteriovenous fistula.&#xD;
Blood sampling in arterioveinous fistula right before a dialysis session</description>
    <arm_group_label>patient without stenosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood sampling in arterioveinous fistula with stenosis</intervention_name>
    <description>Blood sampling in arterioveinous fistula right before the surgery for stenosis of the fistula</description>
    <arm_group_label>patient with stenosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients under a social security scheme&#xD;
&#xD;
          -  Written informed consent obtain&#xD;
&#xD;
          -  18 years old or older&#xD;
&#xD;
          -  end-stage renal failure disease with 3 months dialysis minimum on a native&#xD;
             arteriovenous fistula&#xD;
&#xD;
        Non-inclusion Criteria:&#xD;
&#xD;
          -  Subject under juridicial protection&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Subject already enrolled in a clinical trial involving a drug or an implantable&#xD;
             medical device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Withdrawal of consent&#xD;
&#xD;
          -  Investigator or sponsor decision&#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>Nirvana SADAGHIANLOO</last_name>
    <role>Principal Investigator</role>
    <affiliation>sadaghianloo.n@chu-nice.fr</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nirvana SADAGHIANLOO</last_name>
    <phone>0492038548</phone>
    <email>sadaghianloo.n@chu-nice.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Julie CONTENTI</last_name>
    <email>contenti.j@chu-nice.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU de Nice - Service de chirurgie vasculaire</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nirvana Sadaghianloo, MD</last_name>
      <phone>04 92 03 38 35</phone>
      <email>sadaghianloo.n@chu-nice.fr</email>
    </contact>
    <investigator>
      <last_name>Julie CONTENTI</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>October 12, 2017</last_update_submitted>
  <last_update_submitted_qc>October 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <!-- 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/NCT03270358
org study id: 17-AOI-03
nct id: NCT03270358
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Our hypothesis is that a plasma protein named osteopontin (OPN) could serve as a biological
      predictive marker of acute AVF dysfunction. In several scientific studies, plasma OPN was
      correlated with coronary stent restenosis, and with cardiovascular outcome in patients with
      diabetes and renal insufficiency. This protein is secreted by several cellular types, like
      distal tubule epithelial cells, macrophages, but also fibroblasts and cardiac and vascular
      endothelial cells, in response to several specific stimuli. It acts like a cytokine, inducing
      immunological mechanisms as well as tissue remodeling.

      The main objective of this study is to show that the amount of plasma OPN is higher in
      patients presenting with an AVF stenosis, compared with patients with a functioning AVF.

      OSMOSIS is a monocentric pilot study that will include patients into two groups during 12
      months (no specific follow-up). The control group will include patients that have been
      dialyzed on an AVF, in the dialysis center of Nice University Hospital, for at least 3 months
      without any incident. The experimental group will include hemodialysis patients hospitalized
      in the department of vascular surgery for acute AVF dysfunction, needing endovascular or open
      surgical revision for venous stenosis.

      Blood will be withdrawn right before dialysis or surgical procedure. Plasma OPN will me
      measured by ELISA. Their clinical data would be collected from medical file at the same time.
      After the procedure, patients will be followed-up according to usual protocols.

      To show a significant difference of 100ng/mL plasma OPN between the two groups, with a power
      of 90% and alpha risk of 0.05, we plan to include 76 patients
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Plasmatic osteopontin level
time frame: at inclusion
description: Plasmatic osteopontin level (ng/ml) collected in the patient's arteriovenous fistula.
Control arm: right before a dialysis session
Experimental arm: right before the surgery for stenosis of the fistula
measure: Peripheral plasmatic osteopontin level in the contralateral arm
time frame: at inclusion
description: Peripheral plasmatic osteopontin level (ng/ml) collected in the contralateral arm (to measure the potential bias of a local osteopontin production in the fistula)
measure: Peripheral plasmatic osteopontin level in the contralateral arm
time frame: at inclusion
description: Measure of the plasmatic osteopontin specificity and sensibility on the occurrence of a fistula stenosis (differents tresholds)
measure: Peripheral plasmatic osteopontin level in the contralateral arm
time frame: at inclusion
description: Collection of comorbidity factors (diabetes, arterial hypertension, coronaropathy, overweight (BMI)), clinical factors (age and gender) and treatments at the time of patient's inclusion (anticoagulant, antisludge, antihypertensive drug, statins, erythropoietin)
arm group label: patient with stenosis
arm group type: Experimental
description: Patient coming to the vascular surgery unit to receive surgery regarding their fistula stenosis
arm group label: patient without stenosis
arm group type: Other
description: Patient coming for their dialysis
intervention type: Procedure
intervention name: Blood sampling in arterioveinous fistula without stenosis
description: Plasmatic osteopontin level (ng/ml) collected in the patient's arteriovenous fistula.
Blood sampling in arterioveinous fistula right before a dialysis session
arm group label: patient without stenosis
intervention type: Procedure
intervention name: Blood sampling in arterioveinous fistula with stenosis
description: Blood sampling in arterioveinous fistula right before the surgery for stenosis of the fistula
arm group label: patient with stenosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nirvana SADAGHIANLOO
role: Principal Investigator
affiliation: sadaghianloo.n@chu-nice.fr
last name: Nirvana SADAGHIANLOO
phone: 0492038548
email: sadaghianloo.n@chu-nice.fr
last name: Julie CONTENTI
email: contenti.j@chu-nice.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Constriction, Pathologic