<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/NCT02967471</url>
  </required_header>
  <id_info>
    <org_study_id>ARDS-ILC001</org_study_id>
    <nct_id>NCT02967471</nct_id>
  </id_info>
  <brief_title>Discovery of New Early Detection Biomarkers From Peripheral Blood of Acute Respiratory Distress Syndrome(ARDS)</brief_title>
  <official_title>Discovery of New Early Detection Biomarkers From Peripheral Blood of Acute Respiratory Distress Syndrome(ARDS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Third Affiliated Hospital of Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Third Affiliated Hospital of Southern Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute respiratory distress syndrome (ARDS) has a very poor prognosis and high mortality. To&#xD;
      improve the early diagnosis of ARDS, there is an urgent need for novel biomarkers of ARDS.&#xD;
      This project aims to detect novel biomarkers from peripheral blood , which can improve the&#xD;
      early diagnosis and develop a more efficient therapy to enhance ARDS patient survival rate.&#xD;
      Clinical data and blood sample were recorded before treatment and after treatment. Acute&#xD;
      Physiology And Chronic Health Evaluation III (APACHE III) scores were calculated at&#xD;
      enrolment. Different kinds of lymphocytes from blood samples would be detected by flow&#xD;
      cytometry ,which could be used for discovering high sensitivity and specificity ARDS&#xD;
      biomarker.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Acute respiratory distress syndrome (ARDS) has a very poor prognosis and high&#xD;
      mortality. To improve the early diagnosis of ARDS, there is an urgent need for novel&#xD;
      biomarkers of ARDS. This project aims to detect novel biomarkers from peripheral blood ,&#xD;
      which can improve the early diagnosis and develop a more efficient therapy to enhance ARDS&#xD;
      patient survival rate. Clinical data and blood sample were recorded before treatment and&#xD;
      after treatment. Acute Physiology And Chronic Health Evaluation III (APACHE III) scores were&#xD;
      calculated at enrolment. Different kinds of lymphocytes from blood samples would be detected&#xD;
      by flow cytometry ,which could be used for discovering high sensitivity and specificity ARDS&#xD;
      biomarker.&#xD;
&#xD;
      Eligibility Ages Eligible for Study: 18 years and older Genders Eligible for Study: Both&#xD;
      Accepts Healthy Volunteers: Yes Sampling Method: Probility Samples&#xD;
&#xD;
      Study Population Patients who have ARDS and admitted in hospital&#xD;
&#xD;
      Primary Outcome Measures:&#xD;
&#xD;
      ILC2 and ILC3 number from peripheral blood of ARDS patients&#xD;
&#xD;
      Secondary Outcome Measures:&#xD;
&#xD;
      APACHE III score [ Time Frame: baseline, 1week, 2 weeks ] PaO2/FiO2 ratio[ Time Frame:&#xD;
      baseline, 1week, 2 weeks ] Mortality or multi-organ failure [ Time Frame: 1 month ]&#xD;
&#xD;
      Groups:&#xD;
&#xD;
        1. Mild ARDS PaO2/FiO2=201～300 mmHg，and PEEP or CPAP≤5 cm&#xD;
&#xD;
        2. Moderate ARDS PaO2/FIO2=101～200 mmHg，and PEEP≥5 cm H2O&#xD;
&#xD;
        3. Severe ARDSPaO2/FIO2≤100 mmHg，and PEEP≥10 cm H2O&#xD;
&#xD;
        4. Healthy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2018</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>ILC 3</measure>
    <time_frame>1 months after the onset</time_frame>
    <description>innate lymphoid cells 3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ILC 2</measure>
    <time_frame>1 months after the onset</time_frame>
    <description>innate lymphoid cells 2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>APACHE III score</measure>
    <time_frame>1 months after the onset</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PaO2/FiO2 ratio</measure>
    <time_frame>1 months after the onset</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality or multi-organ failure</measure>
    <time_frame>1 months after the onset</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>ARDS group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have ARDS and admitted in hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages Eligible for Study: 18 years and older Genders Eligible for Study: Both Accepts&#xD;
             Healthy Volunteers: Yes Sampling Method: Probility Samples Study Population：Patients&#xD;
             who have ARDS and admitted in hospital Criteria：Inclusion Criteria:The Berlin&#xD;
             definition of acute respiratory distress syndrome,ATS definition of severe pneumonia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age below 18 years,pregnancy,Expected survival under 24 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jinhong Wang, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>The Third Affiliated Hospital of Southern Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hui Peng, M.M.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Third Affiliated Hospital of Southern Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hong Yang, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>The Third Affiliated Hospital of Southern Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jinhong Wang, M.D.</last_name>
    <phone>+86 13113319966</phone>
    <email>leechy911@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hui Peng, M.M.</last_name>
    <phone>020-62784382</phone>
    <email>penghui230@126.com</email>
  </overall_contact_backup>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 18, 2016</last_update_submitted>
  <last_update_submitted_qc>November 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Third Affiliated Hospital of Southern Medical University</investigator_affiliation>
    <investigator_full_name>Hui Peng</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>ARDS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</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/NCT02967471
org study id: ARDS-ILC001
nct id: NCT02967471
lead sponsor: 
has dmc: Yes
Acute respiratory distress syndrome (ARDS) has a very poor prognosis and high mortality. To
      improve the early diagnosis of ARDS, there is an urgent need for novel biomarkers of ARDS.
      This project aims to detect novel biomarkers from peripheral blood , which can improve the
      early diagnosis and develop a more efficient therapy to enhance ARDS patient survival rate.
      Clinical data and blood sample were recorded before treatment and after treatment. Acute
      Physiology And Chronic Health Evaluation III (APACHE III) scores were calculated at
      enrolment. Different kinds of lymphocytes from blood samples would be detected by flow
      cytometry ,which could be used for discovering high sensitivity and specificity ARDS
      biomarker.
Background Acute respiratory distress syndrome (ARDS) has a very poor prognosis and high
      mortality. To improve the early diagnosis of ARDS, there is an urgent need for novel
      biomarkers of ARDS. This project aims to detect novel biomarkers from peripheral blood ,
      which can improve the early diagnosis and develop a more efficient therapy to enhance ARDS
      patient survival rate. Clinical data and blood sample were recorded before treatment and
      after treatment. Acute Physiology And Chronic Health Evaluation III (APACHE III) scores were
      calculated at enrolment. Different kinds of lymphocytes from blood samples would be detected
      by flow cytometry ,which could be used for discovering high sensitivity and specificity ARDS
      biomarker.

      Eligibility Ages Eligible for Study: 18 years and older Genders Eligible for Study: Both
      Accepts Healthy Volunteers: Yes Sampling Method: Probility Samples

      Study Population Patients who have ARDS and admitted in hospital

      Primary Outcome Measures:

      ILC2 and ILC3 number from peripheral blood of ARDS patients

      Secondary Outcome Measures:

      APACHE III score [ Time Frame: baseline, 1week, 2 weeks ] PaO2/FiO2 ratio[ Time Frame:
      baseline, 1week, 2 weeks ] Mortality or multi-organ failure [ Time Frame: 1 month ]

      Groups:

        1. Mild ARDS PaO2/FiO2=201～300 mmHg，and PEEP or CPAP≤5 cm

        2. Moderate ARDS PaO2/FIO2=101～200 mmHg，and PEEP≥5 cm H2O

        3. Severe ARDSPaO2/FIO2≤100 mmHg，and PEEP≥10 cm H2O

        4. Healthy
observational model: Cohort
time perspective: Prospective
measure: ILC 3
time frame: 1 months after the onset
description: innate lymphoid cells 3
measure: ILC 2
time frame: 1 months after the onset
description: innate lymphoid cells 2
measure: APACHE III score
time frame: 1 months after the onset
measure: PaO2/FiO2 ratio
time frame: 1 months after the onset
measure: Mortality or multi-organ failure
time frame: 1 months after the onset
arm group label: ARDS group
arm group label: control group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jinhong Wang, M.D.
role: Study Chair
affiliation: The Third Affiliated Hospital of Southern Medical University
last name: Hui Peng, M.M.
role: Principal Investigator
affiliation: The Third Affiliated Hospital of Southern Medical University
last name: Hong Yang, M.D.
role: Study Director
affiliation: The Third Affiliated Hospital of Southern Medical University
last name: Jinhong Wang, M.D.
phone: +86 13113319966
email: leechy911@126.com
last name: Hui Peng, M.M.
phone: 020-62784382
email: penghui230@126.com
responsible party type: Principal Investigator
investigator affiliation: The Third Affiliated Hospital of Southern Medical University
investigator full name: Hui Peng
investigator title: Principal Investigator
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Syndrome
sharing ipd: No