<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/NCT04467333</url>
  </required_header>
  <id_info>
    <org_study_id>PH in lung cancer registry</org_study_id>
    <nct_id>NCT04467333</nct_id>
  </id_info>
  <brief_title>Giessen Pulmonary Hypertension in Lung Cancer Registry</brief_title>
  <acronym>PHLHR</acronym>
  <official_title>Giessen Pulmonary Hypertension in Lung Cancer Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Giessen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Giessen</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>
      The aim of this study is to investigate the frequency and implications of pulmonary&#xD;
      hypertension in lung cancer patients. To do so, data will be collected from all lung cancer&#xD;
      patients at the university hospital Giessen. All data will be analyzed for possible hints of&#xD;
      pulmonary hypertension as a comorbidity in lung cancer patients. All information will be&#xD;
      generated from the regular guidelines based course of treatment and there will be no&#xD;
      interventions. This study will serve as a prospective register for all lung cancer patients&#xD;
      treated at the university hospital Giessen.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Anticipated">January 29, 2040</completion_date>
  <primary_completion_date type="Anticipated">January 29, 2024</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>3 Weeks</target_duration>
  <primary_outcome>
    <measure>Pulmonary function test measured via Spirometry.</measure>
    <time_frame>2 years</time_frame>
    <description>vital capacity, total lung capacity, forced expiratory volume in one second, functional vital capacity, diffusing capacity for carbon monoxide, arterial partial pressure of oxygen; all measured as % of predicted normal values.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>sPAP values measured via Echocardiography.</measure>
    <time_frame>2 years</time_frame>
    <description>systolic pulmonary artery pressure (sPAP) measured in millimetre of mercury (mmHg).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body mass index.</measure>
    <time_frame>2 years</time_frame>
    <description>weight and height will be combined to report BMI in kg/m^2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival and Progression Free Survival measured in days.</measure>
    <time_frame>2 years</time_frame>
    <description>Overall Survival and Progression free survival in days will be determined by Kaplan-Meier Analysis .Measuared in (st) (time from diagnosis to death)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurements of the pulmonary artery diameter (PA) and ascending aorta (AA) diameter measured via computed tomography scan. PA and AA will be measured in millimeters.</measure>
    <time_frame>2 years</time_frame>
    <description>PA and AA will be combined to report the PA/AA quotient as indicator for pulmonary hypertension in all lung cancer patients. With a cut off value of ≥ 1 defining pulmonary hypertension.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>6 Minute Walk Test in meters.</measure>
    <time_frame>2 years</time_frame>
    <description>The 6 minute walk test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Medical Research Council Scale (mMRC).</measure>
    <time_frame>2 years</time_frame>
    <description>Scores on the mMRC reach from 0-4, with higher scores indicating greater dyspnea.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>chronic obstructive pulmonary disease assessment test (CAT).</measure>
    <time_frame>2 years</time_frame>
    <description>Scores on the CAT reach from 0-40, with higher scores indicating greater dyspnea.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Pulmonary Hypertension Due to Lung Diseases and Hypoxia</condition>
  <arm_group>
    <arm_group_label>All lung cancer patients</arm_group_label>
    <description>There will not be an intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>All lung cancer patients.</intervention_name>
    <description>There will be no specific interventions. All patients will receive guidelines based therapy of lung cancer and their comorbidities.</description>
    <arm_group_label>All lung cancer patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Equivalent to the average of patients with lung cancer in Germany.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with lung cancer at the University of Giessen lung Cancer Center.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bastian Eul, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>JLU Giessen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Khodr Tello, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>JLU Giessen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bastian Eul, MD</last_name>
    <phone>(+49) 0641/985-42371</phone>
    <email>bastian.eul@innere.med.uni-giessen.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael John Cekay, MD</last_name>
    <email>michael.cekay@innere.med.uni-giessen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University hospital Giessen</name>
      <address>
        <city>Gießen</city>
        <state>Hessen</state>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bastian Eul, MD</last_name>
      <email>bastian.eul@innere.med.uni-giessen.de</email>
    </contact>
    <contact_backup>
      <last_name>Michael John Cekay, MD</last_name>
      <email>michael.cekay@innere.med.uni-giessen.de</email>
    </contact_backup>
    <investigator>
      <last_name>Khodr Tello, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Pullamsetti SS, Kojonazarov B, Storn S, Gall H, Salazar Y, Wolf J, Weigert A, El-Nikhely N, Ghofrani HA, Krombach GA, Fink L, Gattenlohner S, Rapp UR, Schermuly RT, Grimminger F, Seeger W, Savai R. Lung cancer-associated pulmonary hypertension: Role of microenvironmental inflammation based on tumor cell-immune cell cross-talk. Sci Transl Med. 2017 Nov 15;9(416):eaai9048. doi: 10.1126/scitranslmed.aai9048.</citation>
    <PMID>29141888</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>November 10, 2021</last_update_submitted>
  <last_update_submitted_qc>November 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2021</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>Lung Diseases</mesh_term>
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04467333
org study id: PH in lung cancer registry
nct id: NCT04467333
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the frequency and implications of pulmonary
      hypertension in lung cancer patients. To do so, data will be collected from all lung cancer
      patients at the university hospital Giessen. All data will be analyzed for possible hints of
      pulmonary hypertension as a comorbidity in lung cancer patients. All information will be
      generated from the regular guidelines based course of treatment and there will be no
      interventions. This study will serve as a prospective register for all lung cancer patients
      treated at the university hospital Giessen.
observational model: Cohort
time perspective: Prospective
measure: Pulmonary function test measured via Spirometry.
time frame: 2 years
description: vital capacity, total lung capacity, forced expiratory volume in one second, functional vital capacity, diffusing capacity for carbon monoxide, arterial partial pressure of oxygen; all measured as % of predicted normal values.
measure: sPAP values measured via Echocardiography.
time frame: 2 years
description: systolic pulmonary artery pressure (sPAP) measured in millimetre of mercury (mmHg).
measure: Body mass index.
time frame: 2 years
description: weight and height will be combined to report BMI in kg/m^2.
measure: Overall Survival and Progression Free Survival measured in days.
time frame: 2 years
description: Overall Survival and Progression free survival in days will be determined by Kaplan-Meier Analysis .Measuared in (st) (time from diagnosis to death)
measure: Measurements of the pulmonary artery diameter (PA) and ascending aorta (AA) diameter measured via computed tomography scan. PA and AA will be measured in millimeters.
time frame: 2 years
description: PA and AA will be combined to report the PA/AA quotient as indicator for pulmonary hypertension in all lung cancer patients. With a cut off value of ≥ 1 defining pulmonary hypertension.
measure: 6 Minute Walk Test in meters.
time frame: 2 years
description: The 6 minute walk test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance in meters covered over a time of 6 minutes is used as the outcome.
measure: Modified Medical Research Council Scale (mMRC).
time frame: 2 years
description: Scores on the mMRC reach from 0-4, with higher scores indicating greater dyspnea.
measure: chronic obstructive pulmonary disease assessment test (CAT).
time frame: 2 years
description: Scores on the CAT reach from 0-40, with higher scores indicating greater dyspnea.
arm group label: All lung cancer patients
description: There will not be an intervention.
intervention type: Other
intervention name: All lung cancer patients.
description: There will be no specific interventions. All patients will receive guidelines based therapy of lung cancer and their comorbidities.
arm group label: All lung cancer patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bastian Eul, MD
role: Principal Investigator
affiliation: JLU Giessen
last name: Khodr Tello, MD
role: Principal Investigator
affiliation: JLU Giessen
last name: Bastian Eul, MD
phone: (+49) 0641/985-42371
email: bastian.eul@innere.med.uni-giessen.de
last name: Michael John Cekay, MD
email: michael.cekay@innere.med.uni-giessen.de
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Germany
citation: Pullamsetti SS, Kojonazarov B, Storn S, Gall H, Salazar Y, Wolf J, Weigert A, El-Nikhely N, Ghofrani HA, Krombach GA, Fink L, Gattenlohner S, Rapp UR, Schermuly RT, Grimminger F, Seeger W, Savai R. Lung cancer-associated pulmonary hypertension: Role of microenvironmental inflammation based on tumor cell-immune cell cross-talk. Sci Transl Med. 2017 Nov 15;9(416):eaai9048. doi: 10.1126/scitranslmed.aai9048.
PMID: 29141888
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
mesh term: Hypoxia
sharing ipd: Undecided