<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/NCT03270228</url>
  </required_header>
  <id_info>
    <org_study_id>NSP</org_study_id>
    <nct_id>NCT03270228</nct_id>
  </id_info>
  <brief_title>Natural History of Nonspecific Pleuritis Diagnosed After Video-assisted-thoracoscopic-surgery</brief_title>
  <official_title>Natural History of Nonspecific Pleuritis Diagnosed After Video-assisted-thoracoscopic-surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Naestved Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Naestved Hospital</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 investigators want to determine the incidence of malignant disease, type of malignant&#xD;
      disease and overall survival in patients diagnosed with NSP after VATS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using Landspatientregisteret (LPR) (the National Patient register) the investigators will&#xD;
      identify patients who have received a thoracoscopic pleural-biopsy using the SKS-codes KGAC01&#xD;
      and/or KGAA31 and/or KGAC00. From LPR and Cancerregisteret (the National Cancer-register) the&#xD;
      investigators will receive diagnosis and additional descriptive data. From&#xD;
      dødsårsagsregisteret (the National cause-of-death-register) death date and further&#xD;
      descriptive data will be acquired.&#xD;
&#xD;
      Patients with NSP will be identified as patients with no diagnosis six months after&#xD;
      pleural-biopsy, despite a thorough investigation.&#xD;
&#xD;
      Patients with a malignant effusion and non-malignant effusion (with known cause) will be used&#xD;
      for survival analysis and comparison.&#xD;
&#xD;
      Data Data will be registered in the individual patients CRF (Case Report File) (digital) and&#xD;
      will be transferred to a database-program for further processing. Background-variables will&#xD;
      be used to describe the study population. Only study-coordinators will have access to data.&#xD;
      All data including back-up will be stored and kept in a locked cupboard in a locked room.&#xD;
      Only study coordinators possess relevant keys.&#xD;
&#xD;
      Statistics The investigators define significance level (α) as 0.05, and power (β) as 0.80.&#xD;
      Descriptive data will be analysed using nonparametric statistics: Chi2-test for categorical&#xD;
      data and Mann-Whitney for discrete data. Statistical significance is defined as: p-value &lt;&#xD;
      0.05.&#xD;
&#xD;
      The overall survival of patients with NSP will be analysed using a Caplan-Meier plot and&#xD;
      comparison of NSP patients to patients with malignant pleural-effusion the investigators use&#xD;
      the Logrank test.&#xD;
&#xD;
      All statistical tests is conducted using STATA14 (4905 Lakeway Dr., College Station, TX&#xD;
      77845).&#xD;
&#xD;
      Ethics This study will not require the approval from Videnskabsetisk komité (the Health&#xD;
      Research Ethics Committee), but approval will be sought from Datatilsynet (the Danish Data&#xD;
      Protection Agency).&#xD;
&#xD;
      All results will be stored and analysed by computer, and the patients' anonymity will be&#xD;
      secured according to the national laws. The data will be stored (anonymised), after&#xD;
      completion of the study: data containing cpr.-numbers will be stored behind double-lock at&#xD;
      the department.&#xD;
&#xD;
      No patients or investigators have economic incentives for completing the project.&#xD;
&#xD;
      Economy&#xD;
&#xD;
      Expenses related to gathering of data including contact with LPR, Dødsårsagsregisteret and&#xD;
      the Danish Cancer Register are already financed through primary investigators PhD-project.&#xD;
&#xD;
      Publication The results from the study will be presented at international scientific&#xD;
      congresses and published in international journals. Positive as well as negative results will&#xD;
      be published. The scientists right to freely publish the results cannot be limited. All&#xD;
      information will be passed anonymously.&#xD;
&#xD;
      The order of authors will follow the Vancouver Declaration, and will thus reflect the amount&#xD;
      and significance of work relevant to the specific manuscript.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">January 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of cancer</measure>
    <time_frame>10 years</time_frame>
    <description>Percentage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type of cancer</measure>
    <time_frame>10 years</time_frame>
    <description>Lung cancer, mesothelioma etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival of patients</measure>
    <time_frame>10 years</time_frame>
    <description>Comparison of patients with a benign cause, a malignant cause and nonspecific pleuritis</description>
  </secondary_outcome>
  <enrollment type="Actual">10000</enrollment>
  <condition>Pleural Effusion Due to Another Disorder (Disorder)</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nonspecific pleuritis after VATS thoracoscopy</intervention_name>
    <description>Patients with a pleural effusion with unknown origin after a VATS thoracoscopy is classified as nonspecific pleuritis.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with a VATS thoracoscopy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with a VATS thoracoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Simon Reuter, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Naestved Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Naestved Hospital</name>
      <address>
        <city>Naestved</city>
        <zip>4700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>December 15, 2020</last_update_submitted>
  <last_update_submitted_qc>December 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Naestved Hospital</investigator_affiliation>
    <investigator_full_name>Simon Reuter</investigator_full_name>
    <investigator_title>Ph.d.-Student</investigator_title>
  </responsible_party>
  <keyword>Incidence of cancer</keyword>
  <keyword>Survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pleural Effusion</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/NCT03270228
org study id: NSP
nct id: NCT03270228
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators want to determine the incidence of malignant disease, type of malignant
      disease and overall survival in patients diagnosed with NSP after VATS.
Using Landspatientregisteret (LPR) (the National Patient register) the investigators will
      identify patients who have received a thoracoscopic pleural-biopsy using the SKS-codes KGAC01
      and/or KGAA31 and/or KGAC00. From LPR and Cancerregisteret (the National Cancer-register) the
      investigators will receive diagnosis and additional descriptive data. From
      dødsårsagsregisteret (the National cause-of-death-register) death date and further
      descriptive data will be acquired.

      Patients with NSP will be identified as patients with no diagnosis six months after
      pleural-biopsy, despite a thorough investigation.

      Patients with a malignant effusion and non-malignant effusion (with known cause) will be used
      for survival analysis and comparison.

      Data Data will be registered in the individual patients CRF (Case Report File) (digital) and
      will be transferred to a database-program for further processing. Background-variables will
      be used to describe the study population. Only study-coordinators will have access to data.
      All data including back-up will be stored and kept in a locked cupboard in a locked room.
      Only study coordinators possess relevant keys.

      Statistics The investigators define significance level (α) as 0.05, and power (β) as 0.80.
      Descriptive data will be analysed using nonparametric statistics: Chi2-test for categorical
      data and Mann-Whitney for discrete data. Statistical significance is defined as: p-value <
      0.05.

      The overall survival of patients with NSP will be analysed using a Caplan-Meier plot and
      comparison of NSP patients to patients with malignant pleural-effusion the investigators use
      the Logrank test.

      All statistical tests is conducted using STATA14 (4905 Lakeway Dr., College Station, TX
      77845).

      Ethics This study will not require the approval from Videnskabsetisk komité (the Health
      Research Ethics Committee), but approval will be sought from Datatilsynet (the Danish Data
      Protection Agency).

      All results will be stored and analysed by computer, and the patients' anonymity will be
      secured according to the national laws. The data will be stored (anonymised), after
      completion of the study: data containing cpr.-numbers will be stored behind double-lock at
      the department.

      No patients or investigators have economic incentives for completing the project.

      Economy

      Expenses related to gathering of data including contact with LPR, Dødsårsagsregisteret and
      the Danish Cancer Register are already financed through primary investigators PhD-project.

      Publication The results from the study will be presented at international scientific
      congresses and published in international journals. Positive as well as negative results will
      be published. The scientists right to freely publish the results cannot be limited. All
      information will be passed anonymously.

      The order of authors will follow the Vancouver Declaration, and will thus reflect the amount
      and significance of work relevant to the specific manuscript.
observational model: Cohort
time perspective: Retrospective
measure: Incidence of cancer
time frame: 10 years
description: Percentage
measure: Type of cancer
time frame: 10 years
description: Lung cancer, mesothelioma etc.
measure: Survival of patients
time frame: 10 years
description: Comparison of patients with a benign cause, a malignant cause and nonspecific pleuritis
intervention type: Other
intervention name: Nonspecific pleuritis after VATS thoracoscopy
description: Patients with a pleural effusion with unknown origin after a VATS thoracoscopy is classified as nonspecific pleuritis.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
last name: Simon Reuter, MD, PhD
role: Principal Investigator
affiliation: Naestved Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Naestved Hospital
investigator full name: Simon Reuter
investigator title: Ph.d.-Student
mesh term: Pleural Effusion