<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/NCT03250585</url>
  </required_header>
  <id_info>
    <org_study_id>HM20010698</org_study_id>
    <nct_id>NCT03250585</nct_id>
  </id_info>
  <brief_title>sPLA2 in EBC During Acute Chest Syndrome</brief_title>
  <official_title>Secretory Phospholipases A2 in Exhaled Breath Condensate From Sickle Cell Patients With Acute Chest Syndrome: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Virginia Commonwealth University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Secretory phosholipases A2 (sPLA2) are significantly elevated in the plasma of sickle cell&#xD;
      disease patients with acute chest syndrome (ACS), and similar enzymes have been measured in&#xD;
      exhaled breath condensate (EBC), which is collected easily and non-invasively. The&#xD;
      investigators hypothesize that sPLA2 will be measurable in EBC samples from sickle cell&#xD;
      patients with acute chest syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research study is to test the ease and effectiveness of collecting&#xD;
      exhaled breath condensate (liquid) to measure levels of a biomarker, secretory phospholipases&#xD;
      A2 (sPLA2) in people with sickle cell disease during an attack of acute chest syndrome. sPLA2&#xD;
      levels have been reported to be much higher in persons with acute chest syndrome and might be&#xD;
      useful to diagnose and to evaluate the effects of therapy.&#xD;
&#xD;
      Serial monitoring of plasma sPLA2 levels might lead to earlier or more accurate detection of&#xD;
      acute chest syndrome and monitoring of its progression or improvement in patients with sickle&#xD;
      cell disease. However, there is a significant inherent risk of frequent blood collection&#xD;
      further dropping the blood (hemoglobin) levels of an already anemic patient. If sPLA2 can be&#xD;
      measured in exhaled breath condensate, this non-invasive and well-tolerated sample collection&#xD;
      might allow for serial monitoring of the enzyme without depleting the patient's already&#xD;
      diminished blood supply.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2018</start_date>
  <completion_date type="Actual">June 14, 2018</completion_date>
  <primary_completion_date type="Actual">June 14, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>sPLA2 Measurement in EBC during ACS</measure>
    <time_frame>Time point 1 (within either 48 hours of admission or time of diagnosis of ACS, if not present on admission)</time_frame>
    <description>sPLA2 level in EBC at Time point 1 (during acute ACS episode) as measured by ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>sPLA2 Levels in EBC during ACS versus Steady-State</measure>
    <time_frame>Time point 1 to Time point 2 (at 2 week follow-up)</time_frame>
    <description>Comparison of sPLA2 levels in EBC from Time point 1 (during acute illness) and Time Point 2 (return to baseline status at 2 week follow up).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sPLA2 levels in EBC versus Plasma</measure>
    <time_frame>Time point 1 (within either 48 hours of admission or time of diagnosis of ACS, if not present on admission)]</time_frame>
    <description>Difference in sPLA2 levels from EBC compared with Plasma during Time point 1 (during acute illness)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">6</enrollment>
  <condition>Sickle Cell Disease</condition>
  <condition>Acute Chest Syndrome</condition>
  <arm_group>
    <arm_group_label>Sickle Cell Patients with Acute Chest Syndrome</arm_group_label>
    <description>Sickle cell patients with active acute chest syndrome (ACS) from which samples of EBC and plasma will be collected during acute illness within 48 hours of admission with or diagnosis of ACS (Time point 1) in 3 sessions each 1 hour apart (Time point 1a, 1b, and 1c), and 2 weeks after discharge when have returned to steady-state (Time point 2). Time point 2 samples will serve as control (baseline) samples.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Exhaled Breath Condensate (EBC)</intervention_name>
    <description>Serial EBC samples will be collected within 48 hours of acute chest syndrome (ACS) diagnosis and at 2 week follow up</description>
    <arm_group_label>Sickle Cell Patients with Acute Chest Syndrome</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Plasma Sample</intervention_name>
    <description>Serial plasma samples will be collected within 48 hours of acute chest syndrome (ACS) diagnosis and at 2 week follow up</description>
    <arm_group_label>Sickle Cell Patients with Acute Chest Syndrome</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Sickle cell patients with acute chest syndrome&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of sickle cell anemia (the most severe types of sickle cell disease) as&#xD;
             demonstrated by one of the following genotypes: HbSS, HbSβ0&#xD;
&#xD;
          2. Age ≥ 7 and &lt; 40 years&#xD;
&#xD;
          3. Diagnosis of ACS as defined below&#xD;
&#xD;
          4. EBC collection able to be initiated within 48 hours of diagnosis of ACS&#xD;
&#xD;
        Definition of acute chest syndrome to be used: New radiographic pulmonary infiltrate of at&#xD;
        least one complete lung segment in addition to 2 or more of the following symptoms: fever,&#xD;
        chest pain, dyspnea, tachypnea, hypoxia. Given the small number of subjects in this&#xD;
        feasibility study, we are using the more conservative definition in order to ensure samples&#xD;
        are from patients with true ACS. This will increase the likelihood that sPLA2 levels will&#xD;
        be high enough for measurement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Blood product transfusion in the previous 3 months (due to potential alterations in&#xD;
             biomarkers, including sPLA2)&#xD;
&#xD;
          2. Chronic inflammatory conditions other than sickle cell (due to elevation from baseline&#xD;
             of sPLA2 in inflammatory conditions)&#xD;
&#xD;
          3. Physical inability to correctly breathe into the mouthpiece for the required amount of&#xD;
             time without compromising respiratory status&#xD;
&#xD;
          4. Intubated patients (though EBC can be measured in intubated patients, we will not&#xD;
             include this subpopulation for the purpose of this study)&#xD;
&#xD;
          5. Pregnancy (due to the hematologic and respiratory changes that physiologically occur&#xD;
             during gestation)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Davis D Michael, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>September 24, 2018</last_update_submitted>
  <last_update_submitted_qc>September 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acute chest syndrome</keyword>
  <keyword>secretory phospholipases A2</keyword>
  <keyword>exhaled breath condensate</keyword>
  <keyword>sickle cell disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Chest Syndrome</mesh_term>
    <mesh_term>Anemia, Sickle Cell</mesh_term>
    <mesh_term>Syndrome</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/NCT03250585
org study id: HM20010698
nct id: NCT03250585
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Secretory phosholipases A2 (sPLA2) are significantly elevated in the plasma of sickle cell
      disease patients with acute chest syndrome (ACS), and similar enzymes have been measured in
      exhaled breath condensate (EBC), which is collected easily and non-invasively. The
      investigators hypothesize that sPLA2 will be measurable in EBC samples from sickle cell
      patients with acute chest syndrome.
The purpose of this research study is to test the ease and effectiveness of collecting
      exhaled breath condensate (liquid) to measure levels of a biomarker, secretory phospholipases
      A2 (sPLA2) in people with sickle cell disease during an attack of acute chest syndrome. sPLA2
      levels have been reported to be much higher in persons with acute chest syndrome and might be
      useful to diagnose and to evaluate the effects of therapy.

      Serial monitoring of plasma sPLA2 levels might lead to earlier or more accurate detection of
      acute chest syndrome and monitoring of its progression or improvement in patients with sickle
      cell disease. However, there is a significant inherent risk of frequent blood collection
      further dropping the blood (hemoglobin) levels of an already anemic patient. If sPLA2 can be
      measured in exhaled breath condensate, this non-invasive and well-tolerated sample collection
      might allow for serial monitoring of the enzyme without depleting the patient's already
      diminished blood supply.
observational model: Case-Only
time perspective: Prospective
measure: sPLA2 Measurement in EBC during ACS
time frame: Time point 1 (within either 48 hours of admission or time of diagnosis of ACS, if not present on admission)
description: sPLA2 level in EBC at Time point 1 (during acute ACS episode) as measured by ELISA
measure: sPLA2 Levels in EBC during ACS versus Steady-State
time frame: Time point 1 to Time point 2 (at 2 week follow-up)
description: Comparison of sPLA2 levels in EBC from Time point 1 (during acute illness) and Time Point 2 (return to baseline status at 2 week follow up).
measure: sPLA2 levels in EBC versus Plasma
time frame: Time point 1 (within either 48 hours of admission or time of diagnosis of ACS, if not present on admission)]
description: Difference in sPLA2 levels from EBC compared with Plasma during Time point 1 (during acute illness)
arm group label: Sickle Cell Patients with Acute Chest Syndrome
description: Sickle cell patients with active acute chest syndrome (ACS) from which samples of EBC and plasma will be collected during acute illness within 48 hours of admission with or diagnosis of ACS (Time point 1) in 3 sessions each 1 hour apart (Time point 1a, 1b, and 1c), and 2 weeks after discharge when have returned to steady-state (Time point 2). Time point 2 samples will serve as control (baseline) samples.
intervention type: Diagnostic Test
intervention name: Exhaled Breath Condensate (EBC)
description: Serial EBC samples will be collected within 48 hours of acute chest syndrome (ACS) diagnosis and at 2 week follow up
arm group label: Sickle Cell Patients with Acute Chest Syndrome
intervention type: Diagnostic Test
intervention name: Plasma Sample
description: Serial plasma samples will be collected within 48 hours of acute chest syndrome (ACS) diagnosis and at 2 week follow up
arm group label: Sickle Cell Patients with Acute Chest Syndrome
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 30 Years
healthy volunteers: No
last name: Davis D Michael, PhD
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acute Chest Syndrome
mesh term: Anemia, Sickle Cell
mesh term: Syndrome