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/NCT05998512</url>
    </required_header>
    <id_info>
      <org_study_id>PMP/00083</org_study_id>
      <nct_id>NCT05998512</nct_id>
    </id_info>
    <brief_title>Integrating Molecular, Genomic, Morphology and Environmental Features to Improve Precision Diagnosis and Treatment in Interstitial Lung Diseases (PRECISION-ILD)</brief_title>
    <acronym>PRECISION-ILD</acronym>
    <official_title>Integrating Molecular, Genomic, Morphology and Environmental Features to Improve Precision Diagnosis and Treatment in Interstitial Lung Diseases (PRECISION-ILD)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institut d'Investigació Biomèdica de Bellvitge</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institut d'Investigació Biomèdica de Bellvitge</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Integrating Molecular, Genomic, Morphology and Environmental Features to Improve Precision&#xD;
        Diagnosis and Treatment in Interstitial Lung Diseases (PRECISION-ILD)&#xD;
  &#xD;
        Background: Interstitial Lung Diseases (ILDs) are a heterogeneous group of &gt;100 different,&#xD;
        rare diseases, which share the fate of progressive scarring and, ultimately, death. Two&#xD;
        anti-fibrotic drugs have demonstrated to slow-down fibrotic progression and&#xD;
        steroids/immunosuppressants are commonly used for inflammatory-driven ILDs. However,&#xD;
        patient's response to therapeutic options is variable and unpredictable. Similarly, setting a&#xD;
        correct diagnosis is difficult in most cases, especially when patients are too sick for&#xD;
        invasive procedures.&#xD;
  &#xD;
        Objectives: (1) To investigate the differences and commonalities in genetic, genomic and&#xD;
        environmental exposures/lifestyle in fibrotic ILDs depending on the entity, disease behavior&#xD;
        (progressive fibrosis) and treatment response; (2) To integrate the biomarkers that most&#xD;
        impact on prognosis and treatment response in diagnostic algorithms; and (3) To explore the&#xD;
        feasibility and cost of implementing a P4 strategy in clinical practice for fibrotic ILDs.&#xD;
  &#xD;
        Methods: The investigators will extend, update and unify existing ILD cohorts (Spanish SEPAR&#xD;
        ILD Reg, Observatory IPF.cat, CIBERES IPF and Familial ILD cohorts) in whom the researchers&#xD;
        will: (1) record demographic, epidemiological, clinical, physiological and lung morphology&#xD;
        (radiological +/- histological) information; (2) obtain genetic variation, telomere length,&#xD;
        and serum protein markers; (3) investigate environmental exposures (including air-pollution),&#xD;
        (4) apply to integrative analytical methods to identify endotypes, predictive biomarkers of&#xD;
        disease trajectories, theragnostic biomarkers and new therapeutic targets. Results (5) will&#xD;
        be validated in other fibrotic ILD cohorts (e.g.EuILDRegistry, Mexican fibrotic ILD&#xD;
        Registry). Besides, the investigators will explore how to translate this P4 medicine approach&#xD;
        in clinical practice; (6) implementing a predictive score for prognosis and improving the&#xD;
        diagnostic approach through biological data to reduce invasive procedures, and (7) estimate&#xD;
        educational requirement and potential health cost implications.&#xD;
  &#xD;
        Viability:This project is viable because: (1) cohorts already exist and can be expanded and&#xD;
        updated; (2) investigators have ample expertise in translational research and actively&#xD;
        participate in ILD consortia; (3) required knowledge and methodology is already in being used&#xD;
        by the consortium.&#xD;
  &#xD;
        Clinical relevance: Due to the lethality, high social and economic burden of fibrotic ILDs,&#xD;
        identifying the best diagnostic and therapeutic approach through preventive, personalized and&#xD;
        precise measures is a unique opportunity to improve survival in these patients and efficiency&#xD;
        of health-care resources.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 10, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>12 Months</target_duration>
    <primary_outcome>
      <measure>Differences and commonalities in genetic, genomic and environmental exposures/lifestyle in fibrotic ILDs depending on the entity, disease behavior (progressive fibrosis) and treatment response</measure>
      <time_frame>3 years</time_frame>
      <description>Record demographic, epidemiological, clinical, physiological and lung morphology (radiological +/- histological) information. Obtain genetic variation, telomere length, and serum protein markers. Investigate environmental exposures (including air-pollution)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Integration of the biomarkers that most impact on prognosis and treatment response in diagnostic algorithms</measure>
      <time_frame>3 years</time_frame>
      <description>Integrative analytical methods to identify endotypes, predictive biomarkers of disease trajectories, theragnostic biomarkers and new therapeutic targets.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility and cost of implementing a P4 strategy in clinical practice for fibrotic ILDs</measure>
      <time_frame>3 years</time_frame>
      <description>Development of a predictive score for prognosis and improving the diagnostic approach through biological data to reduce invasive procedures, and estimation educational requirement and potential health cost implications.</description>
    </primary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Interstitial Lung Disease</condition>
    <condition>Interstitial Fibrosis</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Observational register</intervention_name>
      <description>This is a non-interventional observational registry on patients</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients older than 18 years with diagnosis of fibrotic ILD of any type in the 12 months&#xD;
          prior to inclusion, and radiologic fibrotic changes of at least 5% on chest CT scan.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Age &gt; 18 years&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
            -  Diagnosis of fibrotic ILD of any type in the 12 months prior to inclusion.&#xD;
  &#xD;
            -  Radiologic fibrotic changes of at least 5% on chest CT scan&#xD;
  &#xD;
            -  Ability to comply with the study protocol (in the opinion of the investigator)&#xD;
  &#xD;
            -  Ability to understand the information given and to sign the informed consent form.&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
            -  Severe, advanced stage or life-limiting chronic diseases prior to the diagnosis of&#xD;
               fibrotic ILD, or that represent a high risk of death in the short term (one year after&#xD;
               inclusion), such as could be metastatic oncological metastatic diseases, advanced&#xD;
               dementia, neurodegenerative diseases in a limiting phase.&#xD;
  &#xD;
            -  Pregnancy or breastfeeding&#xD;
  &#xD;
            -  Inability to complete required visits.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Maria Molina</last_name>
      <phone>932607500</phone>
      <phone_ext>8485</phone_ext>
      <email>ufip@bellvitgehospital.cat</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hospital Universitario de Bellvitge</name>
        <address>
          <city>Hospitalet de Llobregat</city>
          <state>Barcelona</state>
          <zip>08907</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jaume Bordas Martinez</last_name>
        <phone>0034 932607689</phone>
        <email>ufip@bellvitgehospital.cat</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital La Princesa</name>
        <address>
          <city>Madrid</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Claudia Valenzuela, PI</last_name>
      </contact>
      <contact_backup>
        <phone>915 20 22 00</phone>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Hospital Virgen del Rocío</name>
        <address>
          <city>Sevilla</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jose Antonio Rodriguez Portal, MD, PhD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Institut d'Investigació Biomèdica de Bellvitge</investigator_affiliation>
      <investigator_full_name>Maria Molina</investigator_full_name>
      <investigator_title>Head of Interstitial Lung Diseases Unit</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Interstitial</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/NCT05998512
  org study id: PMP/00083
  nct id: NCT05998512
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Integrating Molecular, Genomic, Morphology and Environmental Features to Improve Precision
        Diagnosis and Treatment in Interstitial Lung Diseases (PRECISION-ILD)
  
        Background: Interstitial Lung Diseases (ILDs) are a heterogeneous group of >100 different,
        rare diseases, which share the fate of progressive scarring and, ultimately, death. Two
        anti-fibrotic drugs have demonstrated to slow-down fibrotic progression and
        steroids/immunosuppressants are commonly used for inflammatory-driven ILDs. However,
        patient's response to therapeutic options is variable and unpredictable. Similarly, setting a
        correct diagnosis is difficult in most cases, especially when patients are too sick for
        invasive procedures.
  
        Objectives: (1) To investigate the differences and commonalities in genetic, genomic and
        environmental exposures/lifestyle in fibrotic ILDs depending on the entity, disease behavior
        (progressive fibrosis) and treatment response; (2) To integrate the biomarkers that most
        impact on prognosis and treatment response in diagnostic algorithms; and (3) To explore the
        feasibility and cost of implementing a P4 strategy in clinical practice for fibrotic ILDs.
  
        Methods: The investigators will extend, update and unify existing ILD cohorts (Spanish SEPAR
        ILD Reg, Observatory IPF.cat, CIBERES IPF and Familial ILD cohorts) in whom the researchers
        will: (1) record demographic, epidemiological, clinical, physiological and lung morphology
        (radiological +/- histological) information; (2) obtain genetic variation, telomere length,
        and serum protein markers; (3) investigate environmental exposures (including air-pollution),
        (4) apply to integrative analytical methods to identify endotypes, predictive biomarkers of
        disease trajectories, theragnostic biomarkers and new therapeutic targets. Results (5) will
        be validated in other fibrotic ILD cohorts (e.g.EuILDRegistry, Mexican fibrotic ILD
        Registry). Besides, the investigators will explore how to translate this P4 medicine approach
        in clinical practice; (6) implementing a predictive score for prognosis and improving the
        diagnostic approach through biological data to reduce invasive procedures, and (7) estimate
        educational requirement and potential health cost implications.
  
        Viability:This project is viable because: (1) cohorts already exist and can be expanded and
        updated; (2) investigators have ample expertise in translational research and actively
        participate in ILD consortia; (3) required knowledge and methodology is already in being used
        by the consortium.
  
        Clinical relevance: Due to the lethality, high social and economic burden of fibrotic ILDs,
        identifying the best diagnostic and therapeutic approach through preventive, personalized and
        precise measures is a unique opportunity to improve survival in these patients and efficiency
        of health-care resources.
  observational model: Cohort
  time perspective: Prospective
  measure: Differences and commonalities in genetic, genomic and environmental exposures/lifestyle in fibrotic ILDs depending on the entity, disease behavior (progressive fibrosis) and treatment response
  time frame: 3 years
  description: Record demographic, epidemiological, clinical, physiological and lung morphology (radiological +/- histological) information. Obtain genetic variation, telomere length, and serum protein markers. Investigate environmental exposures (including air-pollution)
  measure: Integration of the biomarkers that most impact on prognosis and treatment response in diagnostic algorithms
  time frame: 3 years
  description: Integrative analytical methods to identify endotypes, predictive biomarkers of disease trajectories, theragnostic biomarkers and new therapeutic targets.
  measure: Feasibility and cost of implementing a P4 strategy in clinical practice for fibrotic ILDs
  time frame: 3 years
  description: Development of a predictive score for prognosis and improving the diagnostic approach through biological data to reduce invasive procedures, and estimation educational requirement and potential health cost implications.
  intervention type: Other
  intervention name: Observational register
  description: This is a non-interventional observational registry on patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Maria Molina
  phone: 932607500
  phone ext: 8485
  email: ufip@bellvitgehospital.cat
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: Institut d'Investigació Biomèdica de Bellvitge
  investigator full name: Maria Molina
  investigator title: Head of Interstitial Lung Diseases Unit
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Interstitial
  sharing ipd: No