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/NCT06020547</url>
    </required_header>
    <id_info>
      <org_study_id>CysFiFRa</org_study_id>
      <nct_id>NCT06020547</nct_id>
    </id_info>
    <brief_title>Cystic Fibrosis and Frailtyh What's in Common?</brief_title>
    <official_title>Cystic Fibrosis in Adults and Frailty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Federico II University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Federico II University</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>
        The goal of this observational study is to assess the main clinical and anamnestic&#xD;
        characteristics, and frailty syndrome in an adult Cystic Fibrosis population. The main&#xD;
        question it aims to answer is the possible association of the frailty status with the main&#xD;
        clinical, therapeutical characteristics, including the genotyping classification of Cystic&#xD;
        Fibrosis patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants will be assessed for the pulmonary status by spirometry (for Forced Expiratory&#xD;
        Volume in 1 second [FEV1 - L]; Forced Expiratory Volume in 1 second percent predicted&#xD;
        [ppFEV1%]; Forced Vital Capacity [FVC - L]; Forced Vital Capacity percent predicted [FVC %];&#xD;
        Maximal Mid-Expiratory Flow [MMEF]); for the functional status by evaluating the activities&#xD;
        of daily living [ADLs], and the instrumental ADLs [IADLs]; and for frailty by the Study of&#xD;
        Osteoporotic Fractures [SOF] Index. The height and weight will be also recorded, and Body&#xD;
        Mass Index [BMI] calculated as body weight divided by height squared [Kg/m2]. Body weight&#xD;
        will be measured in a fasting state in the morning with a mechanical balance.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 1, 2022</start_date>
    <completion_date type="Actual">August 1, 2023</completion_date>
    <primary_completion_date type="Actual">June 1, 2023</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Pre-Frail/Frail Status</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Frailty has been assessed by the SOF Index</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">139</enrollment>
    <condition>Frailty Syndrome</condition>
    <condition>Cystic Fibrosis</condition>
    <arm_group>
      <arm_group_label>Adults with Cystic Fibrosis</arm_group_label>
      <description>All patients who met the diagnostic criteria for CF, over 18 years old, with pathological sweat chloride levels (chloride &gt;60 mEq/L) and two CFTR mutations were recruited.&#xD;
  Sweat chloride levels have been tested, and a panel of CFTR mutations screened. The CFTR genotype has been defined through the screening of the most frequent mutations and rearrangements.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          The study population consists of 139 CF patients referred to the Cystic Fibrosis for the&#xD;
          Adults Centre of the University Federico II of Naples.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  who met the diagnostic criteria for CF,&#xD;
  &#xD;
            -  over 18 years old,&#xD;
  &#xD;
            -  pathological sweat chloride levels (chloride &gt;60 mEq/L) and two CFTR mutations&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  who did not meet the diagnostic criteria for CF&#xD;
  &#xD;
            -  under 18 years old&#xD;
  &#xD;
            -  over 18 years old with normal sweat chloride levels (chloride &gt;60 mEq/L)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Graziamaria Corbi, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Federico II University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Cystic Fibrosis for the Adults Centre</name>
        <address>
          <city>Napoli</city>
          <zip>80131</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Federico II University</investigator_affiliation>
      <investigator_full_name>Graziamaria Corbi</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>functional status</keyword>
    <keyword>frailty</keyword>
    <keyword>Cystic Fibrosis</keyword>
    <keyword>geriatric syndrome</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cystic Fibrosis</mesh_term>
      <mesh_term>Fibrosis</mesh_term>
      <mesh_term>Frailty</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>the data will be treated as pooled</ipd_description>
    </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/NCT06020547
  org study id: CysFiFRa
  nct id: NCT06020547
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to assess the main clinical and anamnestic
        characteristics, and frailty syndrome in an adult Cystic Fibrosis population. The main
        question it aims to answer is the possible association of the frailty status with the main
        clinical, therapeutical characteristics, including the genotyping classification of Cystic
        Fibrosis patients.
  Participants will be assessed for the pulmonary status by spirometry (for Forced Expiratory
        Volume in 1 second [FEV1 - L]; Forced Expiratory Volume in 1 second percent predicted
        [ppFEV1%]; Forced Vital Capacity [FVC - L]; Forced Vital Capacity percent predicted [FVC %];
        Maximal Mid-Expiratory Flow [MMEF]); for the functional status by evaluating the activities
        of daily living [ADLs], and the instrumental ADLs [IADLs]; and for frailty by the Study of
        Osteoporotic Fractures [SOF] Index. The height and weight will be also recorded, and Body
        Mass Index [BMI] calculated as body weight divided by height squared [Kg/m2]. Body weight
        will be measured in a fasting state in the morning with a mechanical balance.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Pre-Frail/Frail Status
  time frame: through study completion, an average of 1 year
  description: Frailty has been assessed by the SOF Index
  arm group label: Adults with Cystic Fibrosis
  description: All patients who met the diagnostic criteria for CF, over 18 years old, with pathological sweat chloride levels (chloride >60 mEq/L) and two CFTR mutations were recruited.
  Sweat chloride levels have been tested, and a panel of CFTR mutations screened. The CFTR genotype has been defined through the screening of the most frequent mutations and rearrangements.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  gender based: Yes
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Graziamaria Corbi, MD, PhD
  role: Principal Investigator
  affiliation: Federico II University
  facility: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Federico II University
  investigator full name: Graziamaria Corbi
  investigator title: Associate Professor
  mesh term: Cystic Fibrosis
  mesh term: Fibrosis
  mesh term: Frailty
  sharing ipd: Undecided
  ipd description: the data will be treated as pooled