<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/NCT01698151</url>
  </required_header>
  <id_info>
    <org_study_id>S-20110163</org_study_id>
    <nct_id>NCT01698151</nct_id>
  </id_info>
  <brief_title>Prognosis and Treatment of COPD in Primary Care-use of Biomarkers</brief_title>
  <acronym>PROTECCT-M</acronym>
  <official_title>Prognosis and Treatment of COPD in Primary Care-use of Biomarkers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Ministry of Science, Technology and Innovation, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Region of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational study in primary care aiming to validate biomarkers for chronic&#xD;
      obstructive pulmonary disease (COPD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2016</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>Hospitalization</measure>
    <time_frame>December 1, 2015</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease (COPD)</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients in primary care on the Fyn island, Denmark&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  40 years old or more,&#xD;
&#xD;
          -  diagnosis of COPD in primary care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major psychiatric illness,&#xD;
&#xD;
          -  inability to visit primary care doctor,&#xD;
&#xD;
          -  inability to understand danish language,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frans Boch Waldorff, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern Denmark</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Frans Boch Waldorff, MD, PhD</last_name>
    <phone>+45 6550 7643</phone>
    <email>fwaldorff@health.sdu.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Helle Reintoft Andersen</last_name>
    <phone>+45 6550 3830</phone>
    <email>hereandersen@health.sdu.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nyhegn, Søndergaard, Trabjerg og Vilhelmsen</name>
      <address>
        <city>Middelfart</city>
        <state>Fyn</state>
        <zip>5500</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lene Søndergaard, MD</last_name>
      <phone>+45 23675570</phone>
      <email>lene-soendergaard@dadlnet.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peer Kirkebjerg</name>
      <address>
        <city>Odense C</city>
        <state>Fyn</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Larsen, MD</last_name>
      <phone>+45 66125130</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lægerne J.B. Winsløws Vej</name>
      <address>
        <city>Odense</city>
        <state>Fyn</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Henrik K. Laustrup, MD</last_name>
      <phone>+45 65504001</phone>
      <email>hl@winsloewsvej.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peter Larsen</name>
      <address>
        <city>Odense</city>
        <state>Fyn</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Lægerne Lærkevej</name>
      <address>
        <city>Otterup</city>
        <state>Fyn</state>
        <zip>5450</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Søndersø Lægehus</name>
      <address>
        <city>Søndersø</city>
        <state>Fyn</state>
        <zip>5471</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Aaruplægerne</name>
      <address>
        <city>Aarup</city>
        <zip>5560</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Klaus Roslind, MD</last_name>
      <phone>+45 6443 1024</phone>
      <email>k.roslind@dadlnet.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lægerne i Bullerup</name>
      <address>
        <city>Agedrup</city>
        <zip>5320</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Lægehuset Skelvænget</name>
      <address>
        <city>Assens</city>
        <zip>5610</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ester Vad, MD</last_name>
      <phone>+45 64711065</phone>
      <email>vadiversen@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lægerne Lægehuset</name>
      <address>
        <city>Faaborg</city>
        <zip>5600</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Per Andersen, MD</last_name>
      <phone>+45 62610108</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Per Andersen</name>
      <address>
        <city>Faaborg</city>
        <zip>5600</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Per Andersen, MD</last_name>
      <email>per.andersen@dadlnet.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lægehuset i Gislev</name>
      <address>
        <city>Gislev</city>
        <zip>5854</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Haarbylægerne</name>
      <address>
        <city>Haarby</city>
        <zip>5683</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lisbeth Johansen, MD</last_name>
      <phone>+45 64731616</phone>
      <email>haarbylaegerne@post1.tele.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jordløselægerne</name>
      <address>
        <city>Haarby</city>
        <zip>5683</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mia Skytte Petersen, MD</last_name>
      <phone>+45 64732312</phone>
      <email>mia@halldorgg.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lægerne i Hesselager</name>
      <address>
        <city>Hesselager</city>
        <zip>5874</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Lægerne i Hesselager</name>
      <address>
        <city>Hesselager</city>
        <zip>5874</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tina Riis Jørgensen, Cand.med.</last_name>
      <phone>+45 62271089</phone>
      <email>tinariis@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lægerne Glenthøj &amp; Nielsen</name>
      <address>
        <city>Kerteminde</city>
        <zip>5300</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hanne Nielsen</last_name>
      <phone>+45 65321743</phone>
      <email>birkevej.kerteminde@mail.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lægerne Tronegaard-Madsen og Schmidt</name>
      <address>
        <city>Kerteminde</city>
        <zip>5300</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tronegaard-Madsen, MD</last_name>
      <phone>+45 65321048</phone>
      <email>surlemont@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Muusgaarden</name>
      <address>
        <city>Kerteminde</city>
        <zip>5300</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dorte Ejg Jarbøl, MD</last_name>
      <phone>+45 22486886</phone>
      <email>djarbol@health.sdu.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lægerne i Kværndrup</name>
      <address>
        <city>Kværndrup</city>
        <zip>5772</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tina Riis, MD</last_name>
      <phone>+45 62271089</phone>
      <email>tinariis@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lægerne i Havnegade</name>
      <address>
        <city>Middelfart</city>
        <zip>5500</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeff Sørensen, MD</last_name>
      <phone>+45 64410942</phone>
      <email>laegerneihavnegade@live.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lægehuset i Morud</name>
      <address>
        <city>Morud</city>
        <zip>5462</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elsebeth Lindegaard, MD</last_name>
      <phone>+45 65964125</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lægerne Nr. Voldgade</name>
      <address>
        <city>Nyborg</city>
        <zip>5800</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alice Vesterbjerg, MD</last_name>
      <phone>+45 65310143</phone>
      <email>alis@huslaegerne.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lægerne Nyenstad</name>
      <address>
        <city>Nyborg</city>
        <zip>5800</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Annette Tornøe</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Annette Tornøe, MD</last_name>
      <phone>+4565919146</phone>
      <email>a.tornoe@dadlnet.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kirsten Wengler</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kirsten Wengler, MD</last_name>
      <phone>+4565919146</phone>
      <email>kwengler@dadlnet.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Læge Thore Eriksen</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Lægerne Agertoft og Petersen</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Agertoft, MD</last_name>
      <phone>+66112101</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Almen Medicinsk Lægeklinik</name>
      <address>
        <city>Odense SØ</city>
        <zip>5220</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rasmus Dahl Larsen, MD</last_name>
      <phone>+45 66179017</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Bylægen Peer Kirkebjerg &amp; Speciallæge Nanna Kirkebjerg</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nanna Kirkebjeg, MD</last_name>
      <phone>+45 66 12 51 30</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Læge Bo Gamborg Nielsen</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bo Gamborg Nielsen, MD</last_name>
      <phone>+4566176600</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lægerne Banepladsen</name>
      <address>
        <city>Otterup</city>
        <zip>5450</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Munk, MD</last_name>
      <phone>+45 64821027</phone>
      <email>martinmunk@dadlnet.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lægerne i Østergade</name>
      <address>
        <city>Ringe</city>
        <zip>5750</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Lægehuset Rudkøbing I/S</name>
      <address>
        <city>Rudkøbing</city>
        <zip>5900</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sanne Uhrenholt Andersen</last_name>
      <phone>+45 63511700</phone>
      <email>jv@ruddoc.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lægerne Ørstedsgade</name>
      <address>
        <city>Rudkøbing</city>
        <zip>5900</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jens Stærk Jensen, MD</last_name>
      <phone>+45 62515141</phone>
      <email>laegerne@oerstedsgade.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lægerne Toldbodvej</name>
      <address>
        <city>Svendborg</city>
        <zip>5700</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Henrik Lund, MD</last_name>
      <phone>+45 62214518</phone>
      <email>henrik.lund@dadlnet.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lægehuset i Vissenbjerg</name>
      <address>
        <city>Vissenbjerg</city>
        <zip>5492</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Kanstrup, MD</last_name>
      <phone>+45 64471077</phone>
      <email>5492vissenbjerg@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lægerne i Nr. Lyndelse</name>
      <address>
        <city>Årslev</city>
        <zip>5792</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lisbeth Muncke Møller, Cand.med.</last_name>
      <phone>+45 65901019</phone>
      <email>nrlyn.lc@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>http://www.cekol.dk</url>
    <description>Homepage for study</description>
  </link>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>March 7, 2016</last_update_submitted>
  <last_update_submitted_qc>March 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Frans Boch Waldorff</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Chronic obstructive Pulmonary Disease</keyword>
  <keyword>COPD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT01698151
org study id: S-20110163
nct id: NCT01698151
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This is an observational study in primary care aiming to validate biomarkers for chronic
      obstructive pulmonary disease (COPD).
observational model: Case-Only
time perspective: Prospective
measure: Hospitalization
time frame: December 1, 2015
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 100 Years
healthy volunteers: No
last name: Frans Boch Waldorff, MD, PhD
role: Principal Investigator
affiliation: University of Southern Denmark
last name: Frans Boch Waldorff, MD, PhD
phone: +45 6550 7643
email: fwaldorff@health.sdu.dk
last name: Helle Reintoft Andersen
phone: +45 6550 3830
email: hereandersen@health.sdu.dk
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Denmark
url: http://www.cekol.dk
description: Homepage for study
responsible party type: Principal Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Frans Boch Waldorff
investigator title: Principal Investigator
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive