xml: <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/NCT05962827</url>
    </required_header>
    <id_info>
      <org_study_id>22-AOI-05</org_study_id>
      <secondary_id>2023-A00407-38</secondary_id>
      <nct_id>NCT05962827</nct_id>
    </id_info>
    <brief_title>Testing for Increased Lipoproteins (a) [LP(a)] in Lymphedema Patients: Li-LY</brief_title>
    <acronym>LiLY</acronym>
    <official_title>Testing for Increased Lipoproteins (a) [LP(a)] in Lymphedema Patients: Li-LY</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>
        Lymphedema is a chronic disease that causes lymph to accumulate in the interstitial tissue.&#xD;
        The lymphatic network is involved in the metabolism of lipids and lipoproteins, and this&#xD;
        accumulation leads to lipid deposits in the tissues involved. The level of lipoprotein(a)&#xD;
        [LP(a)] has been shown to be a cardiovascular risk factor, which is partly genetically&#xD;
        determined and influenced by certain factors (chronic renal failure, statin treatment,&#xD;
        sporting activity or a diet low in saturated fatty acids...). Plasma levels of LP(a)&#xD;
        lipoproteins (a) are linearly associated with an increased risk of myocardial infarction and&#xD;
        carotid and femoral vascular stenosis. We currently manage patients with primary or secondary&#xD;
        lymphedema, whatever the etiology, in the vascular medicine and explorations unit at Nice&#xD;
        University Hospital.&#xD;
  &#xD;
        Those taking part in intensive inpatient decongestive therapy benefit from a blood test, in&#xD;
        particular for lipids [total cholesterol, triglycerides, HDL and LDL cholesterol,&#xD;
        apolipoproteins A and B and Lp(a)]. Our team observed an elevated Lp(a) level &gt;30 mg/dL in 10&#xD;
        of the 17 patients in whom we carried out this test (whether or not dyslipidemia existed, and&#xD;
        whether or not it was known or treated). This is a very high prevalence compared with the&#xD;
        general population, in whom an increased level is found in 25% of patients.&#xD;
  &#xD;
        In view of the impact of Lp(a) on cardiovascular risk and the involvement of the lymphatic&#xD;
        system in lipoprotein metabolism, it seems essential to verify our preliminary results on a&#xD;
        larger population. In this multicenter cross-sectional trial, we propose to perform Lp(a)&#xD;
        lipoprotein assays in lymphedema patients to determine whether there is an increase in this&#xD;
        marker in this pathological context. We will also study the concordance of this level with&#xD;
        cardiovascular risk assessment scores such as SCORE2/SCORE2-OP and the coronary calcium&#xD;
        score. We will look for factors influencing plasma LP(a) levels, both general factors&#xD;
        suspected of playing a role and factors specific to lymphedema.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Lymphedema is a chronic disease that causes lymph to accumulate in the interstitial tissue.&#xD;
        The lymphatic network is involved in the metabolism of lipids and lipoproteins, and this&#xD;
        accumulation leads to lipid deposits in the tissues involved. The level of lipoprotein(a)&#xD;
        [LP(a)] has been shown to be a cardiovascular risk factor, which is partly genetically&#xD;
        determined and influenced by certain factors (chronic renal failure, statin treatment,&#xD;
        sporting activity or a diet low in saturated fatty acids...). Plasma levels of LP(a)&#xD;
        lipoproteins (a) are linearly associated with an increased risk of myocardial infarction and&#xD;
        carotid and femoral vascular stenosis. We currently manage patients with primary or secondary&#xD;
        lymphedema, whatever the etiology, in the vascular medicine and explorations unit at Nice&#xD;
        University Hospital.&#xD;
  &#xD;
        Those taking part in intensive inpatient decongestive therapy benefit from a blood test, in&#xD;
        particular for lipids [total cholesterol, triglycerides, HDL and LDL cholesterol,&#xD;
        apolipoproteins A and B and Lp(a)]. Our team observed an elevated Lp(a) level &gt;30 mg/dL in 10&#xD;
        of the 17 patients in whom we carried out this test (whether or not dyslipidemia existed, and&#xD;
        whether or not it was known or treated). This is a very high prevalence compared with the&#xD;
        general population, in whom an increased level is found in 25% of patients.&#xD;
  &#xD;
        In view of the impact of Lp(a) on cardiovascular risk and the involvement of the lymphatic&#xD;
        system in lipoprotein metabolism, it seems essential to verify our preliminary results on a&#xD;
        larger population. In this multicenter cross-sectional trial, we propose to perform Lp(a)&#xD;
        lipoprotein assays in lymphedema patients to determine whether there is an increase in this&#xD;
        marker in this pathological context. We will also study the concordance of this level with&#xD;
        cardiovascular risk assessment scores such as SCORE2/SCORE2-OP and the coronary calcium&#xD;
        score. We will look for factors influencing plasma LP(a) levels, both general factors&#xD;
        suspected of playing a role and factors specific to lymphedema.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Determine the prevalence of hyperlipoproteinemia (a) in a population of patients with primary or secondary lymphedema</measure>
      <time_frame>day 0</time_frame>
      <description>The primary endpoint will be lipoprotein (a) &gt; 30 mg/dL, defining hyperlipoproteinemia (a).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To study the modification of the SCORE-2 /SCORE-OP index of cardiovascular risk assessment at re-evaluation,</measure>
      <time_frame>day 5</time_frame>
      <description>To study the modification of the SCORE-2 /SCORE-OP index</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To study the modification of the cardiovascular risk assessment calcium score at reassessment, taking into account the presence of hyperlipoproteinemia (a).</measure>
      <time_frame>day 5</time_frame>
      <description>cardiovascular risk assessment calcium score at reassessment,</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Lymphedema</condition>
    <arm_group>
      <arm_group_label>Determine the prevalence of hyperlipoproteinemia (a) in a population of patients with lymphedema</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The primary endpoint will be lipoprotein (a) &gt; 30 mg/dL, defining hyperlipoproteinemia (a).</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>lipoprotein (a)</intervention_name>
      <description>dosage of lipoprotein (a)</description>
      <arm_group_label>Determine the prevalence of hyperlipoproteinemia (a) in a population of patients with lymphedema</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients over 18 years of age.&#xD;
  &#xD;
            -  Patient with primary or secondary lymphedema confirmed at consultation or in day&#xD;
               hospital.&#xD;
  &#xD;
            -  Signature of informed consent.&#xD;
  &#xD;
            -  Person affiliated to or benefiting from a social security scheme&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Person refusing informed consent.&#xD;
  &#xD;
            -  Pregnant or breast-feeding women (urine pregnancy test performed in women of&#xD;
               -childbearing age).&#xD;
  &#xD;
            -  Patients undergoing secondary cardiovascular prevention (MI, stroke, AOMI, etc.).&#xD;
  &#xD;
            -  Persons deprived of their liberty by judicial or administrative decision, persons&#xD;
               under legal protection.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Verena FASSBENDER</last_name>
      <role>Principal Investigator</role>
      <affiliation>Centre Hospitalier Universitaire de Nice</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>MARION F CAUSERET</last_name>
      <phone>0492034702</phone>
      <email>causeret.m@chu-nice.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>CAUSERET Marion</name>
        <address>
          <city>Nice</city>
          <state>Centre Antoine Lacassagne</state>
          <zip>06003</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Marion CAUSERET</last_name>
        <phone>0492034702</phone>
        <email>causeret.m@chu-nice.fr</email>
      </contact>
      <investigator>
        <last_name>élise GILBERT</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</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>Lymphedema</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05962827
  org study id: 22-AOI-05
  secondary id: 2023-A00407-38
  nct id: NCT05962827
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Lymphedema is a chronic disease that causes lymph to accumulate in the interstitial tissue.
        The lymphatic network is involved in the metabolism of lipids and lipoproteins, and this
        accumulation leads to lipid deposits in the tissues involved. The level of lipoprotein(a)
        [LP(a)] has been shown to be a cardiovascular risk factor, which is partly genetically
        determined and influenced by certain factors (chronic renal failure, statin treatment,
        sporting activity or a diet low in saturated fatty acids...). Plasma levels of LP(a)
        lipoproteins (a) are linearly associated with an increased risk of myocardial infarction and
        carotid and femoral vascular stenosis. We currently manage patients with primary or secondary
        lymphedema, whatever the etiology, in the vascular medicine and explorations unit at Nice
        University Hospital.
  
        Those taking part in intensive inpatient decongestive therapy benefit from a blood test, in
        particular for lipids [total cholesterol, triglycerides, HDL and LDL cholesterol,
        apolipoproteins A and B and Lp(a)]. Our team observed an elevated Lp(a) level >30 mg/dL in 10
        of the 17 patients in whom we carried out this test (whether or not dyslipidemia existed, and
        whether or not it was known or treated). This is a very high prevalence compared with the
        general population, in whom an increased level is found in 25% of patients.
  
        In view of the impact of Lp(a) on cardiovascular risk and the involvement of the lymphatic
        system in lipoprotein metabolism, it seems essential to verify our preliminary results on a
        larger population. In this multicenter cross-sectional trial, we propose to perform Lp(a)
        lipoprotein assays in lymphedema patients to determine whether there is an increase in this
        marker in this pathological context. We will also study the concordance of this level with
        cardiovascular risk assessment scores such as SCORE2/SCORE2-OP and the coronary calcium
        score. We will look for factors influencing plasma LP(a) levels, both general factors
        suspected of playing a role and factors specific to lymphedema.
  Lymphedema is a chronic disease that causes lymph to accumulate in the interstitial tissue.
        The lymphatic network is involved in the metabolism of lipids and lipoproteins, and this
        accumulation leads to lipid deposits in the tissues involved. The level of lipoprotein(a)
        [LP(a)] has been shown to be a cardiovascular risk factor, which is partly genetically
        determined and influenced by certain factors (chronic renal failure, statin treatment,
        sporting activity or a diet low in saturated fatty acids...). Plasma levels of LP(a)
        lipoproteins (a) are linearly associated with an increased risk of myocardial infarction and
        carotid and femoral vascular stenosis. We currently manage patients with primary or secondary
        lymphedema, whatever the etiology, in the vascular medicine and explorations unit at Nice
        University Hospital.
  
        Those taking part in intensive inpatient decongestive therapy benefit from a blood test, in
        particular for lipids [total cholesterol, triglycerides, HDL and LDL cholesterol,
        apolipoproteins A and B and Lp(a)]. Our team observed an elevated Lp(a) level >30 mg/dL in 10
        of the 17 patients in whom we carried out this test (whether or not dyslipidemia existed, and
        whether or not it was known or treated). This is a very high prevalence compared with the
        general population, in whom an increased level is found in 25% of patients.
  
        In view of the impact of Lp(a) on cardiovascular risk and the involvement of the lymphatic
        system in lipoprotein metabolism, it seems essential to verify our preliminary results on a
        larger population. In this multicenter cross-sectional trial, we propose to perform Lp(a)
        lipoprotein assays in lymphedema patients to determine whether there is an increase in this
        marker in this pathological context. We will also study the concordance of this level with
        cardiovascular risk assessment scores such as SCORE2/SCORE2-OP and the coronary calcium
        score. We will look for factors influencing plasma LP(a) levels, both general factors
        suspected of playing a role and factors specific to lymphedema.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Determine the prevalence of hyperlipoproteinemia (a) in a population of patients with primary or secondary lymphedema
  time frame: day 0
  description: The primary endpoint will be lipoprotein (a) > 30 mg/dL, defining hyperlipoproteinemia (a).
  measure: To study the modification of the SCORE-2 /SCORE-OP index of cardiovascular risk assessment at re-evaluation,
  time frame: day 5
  description: To study the modification of the SCORE-2 /SCORE-OP index
  measure: To study the modification of the cardiovascular risk assessment calcium score at reassessment, taking into account the presence of hyperlipoproteinemia (a).
  time frame: day 5
  description: cardiovascular risk assessment calcium score at reassessment,
  arm group label: Determine the prevalence of hyperlipoproteinemia (a) in a population of patients with lymphedema
  arm group type: Experimental
  description: The primary endpoint will be lipoprotein (a) > 30 mg/dL, defining hyperlipoproteinemia (a).
  intervention type: Diagnostic Test
  intervention name: lipoprotein (a)
  description: dosage of lipoprotein (a)
  arm group label: Determine the prevalence of hyperlipoproteinemia (a) in a population of patients with lymphedema
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Verena FASSBENDER
  role: Principal Investigator
  affiliation: Centre Hospitalier Universitaire de Nice
  last name: MARION F CAUSERET
  phone: 0492034702
  email: causeret.m@chu-nice.fr
  facility: 
  contact: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Lymphedema
  sharing ipd: No