<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/NCT03276715</url>
  </required_header>
  <id_info>
    <org_study_id>UW 16-307</org_study_id>
    <nct_id>NCT03276715</nct_id>
  </id_info>
  <brief_title>Prognostic Factors on Malignant Pleural Effusion</brief_title>
  <official_title>A Cohort Study of Prognostic Factors in Lung Cancer Patients With Malignant Pleural Effusion (MPE).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</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>
      Malignant pleural effusion can occur in up to half of the patients with metastatic disease.&#xD;
      It can cause shortness of breath to patients and so far there is no protocol on its&#xD;
      management.&#xD;
&#xD;
      The study is looking at patients with malignant pleural effusion and aims to identify its&#xD;
      prognostic factors.&#xD;
&#xD;
      Pleural fluid and blood analysis will be performed as in the standard of care and results&#xD;
      will be collected at the start of diagnosis. This will not affect subsequent management plan.&#xD;
      Patients' disease course will be followed up and progress data will be collected. Data will&#xD;
      then be analysed to identify relevant prognostic factors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Malignant pleural effusion (MPE) is common, and is estimated to affect up to a half of&#xD;
      patients with malignancy, either at the time or during subsequent clinical course after the&#xD;
      diagnosis of malignancy. Lung cancer is the most common cause of MPE, followed by breast&#xD;
      cancer, lymphoma, unknown primary genitourinary and gastrointestinal carcinoma. Pleural&#xD;
      involvement indicates dissemination of malignancy and suggests a poorer prognosis and the&#xD;
      median survival rate ranges from 3 to 12 months, with lung cancer showing the shortest&#xD;
      survival among Caucasian cohorts. Patients with MPE frequently suffer from effusion related&#xD;
      symptoms requiring therapeutic drainage. Conventionally, the options of therapeutic drainage&#xD;
      of MPE include needle aspiration, and intercostal drain insertion with or without chemical&#xD;
      pleurodesis. Needle aspiration allows quick relief of effusion and symptoms, though the&#xD;
      volume of pleural effusion being aspirated with each attempt of needle puncture is limited to&#xD;
      1-1.5 litres, and repeated puncture involves risks of complications. Intercostal drain&#xD;
      insertion will allow gradual drainage of large pleural effusion over days, but the&#xD;
      shortcomings being the long hospitalization of at least a week, and the presence of trapped&#xD;
      lung would preclude chemical pleurodesis for definitive fluid control. Up to 40% of MPE&#xD;
      patients still require repeated pleural drainage procedure, even after Talc chemical&#xD;
      pleurodesis. The much longer hospitalization period is considered unfavourable for patients&#xD;
      with limited lifespan in terms of weeks or a few months, who would spend more time with their&#xD;
      family. In recent few years, indwelling pleural catheter (IPC) has provided a relatively&#xD;
      novel option of palliative MPE drainage, on an ambulatory out-patient setting. IPC has been&#xD;
      reported to be cost-effective, in particular for patients with survival of less than 14&#xD;
      weeks. With the limited time span, it is important to balance between the aim of symptomatic&#xD;
      relief and maintaining patient's quality of life. Invasive procedures and prolonged&#xD;
      hospitalisation can cause great distress to patients. Predicted survival of patients with MPE&#xD;
      would be important in informing the most suitable method for relieving MPE. Previous studies&#xD;
      have identified relevant factors on prediction of survival in patients with malignant pleural&#xD;
      effusion but so far, there is no data for Chinese patients. The LENT scoring system (pleural&#xD;
      fluid lactate dehydrogenase, Eastern Cooperative Oncology Group performance score, neutrophil&#xD;
      -to-lymphocyte ratio and tumour type) is a new validated prognostic score in malignant&#xD;
      pleural effusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">October 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</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 Years</target_duration>
  <primary_outcome>
    <measure>Further pleural intervention</measure>
    <time_frame>3 years</time_frame>
    <description>Rate of fluid recurrence requiring invasive pleural interventions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>3 years</time_frame>
    <description>survival of lung cancer patient with malignant pleural effusion</description>
  </secondary_outcome>
  <enrollment type="Actual">233</enrollment>
  <condition>Pleural Effusion, Malignant</condition>
  <condition>Lung Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Retrospective retrieval of list of subjects diagnosed to have malignant pleural effusion&#xD;
        (MPE). Subjects diagnosed to have MPE who are under the care of Department of Medicine in&#xD;
        Queen Mary Hospital, Hong Kong, will be invited to participate in the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  malignant pleural effusion (MPE) due to lung cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  workup of MPE (pleural fluid results, blood test results, or treatment history) not&#xD;
             available&#xD;
&#xD;
          -  Patients unwilling to join study (for prospective recruitment)&#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>Ka Yan Chiang, MBBS(HK)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen Mary Hospital, Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>Clive AO, Kahan BC, Hooper CE, Bhatnagar R, Morley AJ, Zahan-Evans N, Bintcliffe OJ, Boshuizen RC, Fysh ET, Tobin CL, Medford AR, Harvey JE, van den Heuvel MM, Lee YC, Maskell NA. Predicting survival in malignant pleural effusion: development and validation of the LENT prognostic score. Thorax. 2014 Dec;69(12):1098-104. doi: 10.1136/thoraxjnl-2014-205285. Epub 2014 Aug 6.</citation>
    <PMID>25100651</PMID>
  </reference>
  <reference>
    <citation>Anevlavis S, Kouliatsis G, Sotiriou I, Koukourakis MI, Archontogeorgis K, Karpathiou G, Giatromanolaki A, Froudarakis ME. Prognostic factors in patients presenting with pleural effusion revealing malignancy. Respiration. 2014;87(4):311-6. doi: 10.1159/000356764. Epub 2014 Jan 22.</citation>
    <PMID>24457947</PMID>
  </reference>
  <reference>
    <citation>Bielsa S, Salud A, Martinez M, Esquerda A, Martin A, Rodriguez-Panadero F, Porcel JM. Prognostic significance of pleural fluid data in patients with malignant effusion. Eur J Intern Med. 2008 Jul;19(5):334-9. doi: 10.1016/j.ejim.2007.09.014. Epub 2007 Nov 8.</citation>
    <PMID>18549935</PMID>
  </reference>
  <reference>
    <citation>Thomas R, Francis R, Davies HE, Lee YC. Interventional therapies for malignant pleural effusions: the present and the future. Respirology. 2014 Aug;19(6):809-22. doi: 10.1111/resp.12328. Epub 2014 Jun 19.</citation>
    <PMID>24947955</PMID>
  </reference>
  <reference>
    <citation>Lui MM, Fitzgerald DB, Lee YC. Phenotyping malignant pleural effusions. Curr Opin Pulm Med. 2016 Jul;22(4):350-5. doi: 10.1097/MCP.0000000000000267.</citation>
    <PMID>27055073</PMID>
  </reference>
  <reference>
    <citation>Davies HE, Mishra EK, Kahan BC, Wrightson JM, Stanton AE, Guhan A, Davies CW, Grayez J, Harrison R, Prasad A, Crosthwaite N, Lee YC, Davies RJ, Miller RF, Rahman NM. Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: the TIME2 randomized controlled trial. JAMA. 2012 Jun 13;307(22):2383-9. doi: 10.1001/jama.2012.5535.</citation>
    <PMID>22610520</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Lui Mei Sze</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>malignant pleural effusion</keyword>
  <keyword>lung cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Pleural Effusion, Malignant</mesh_term>
    <mesh_term>Pleural Effusion</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 30, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03276715/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03276715
org study id: UW 16-307
nct id: NCT03276715
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Malignant pleural effusion can occur in up to half of the patients with metastatic disease.
      It can cause shortness of breath to patients and so far there is no protocol on its
      management.

      The study is looking at patients with malignant pleural effusion and aims to identify its
      prognostic factors.

      Pleural fluid and blood analysis will be performed as in the standard of care and results
      will be collected at the start of diagnosis. This will not affect subsequent management plan.
      Patients' disease course will be followed up and progress data will be collected. Data will
      then be analysed to identify relevant prognostic factors.
Malignant pleural effusion (MPE) is common, and is estimated to affect up to a half of
      patients with malignancy, either at the time or during subsequent clinical course after the
      diagnosis of malignancy. Lung cancer is the most common cause of MPE, followed by breast
      cancer, lymphoma, unknown primary genitourinary and gastrointestinal carcinoma. Pleural
      involvement indicates dissemination of malignancy and suggests a poorer prognosis and the
      median survival rate ranges from 3 to 12 months, with lung cancer showing the shortest
      survival among Caucasian cohorts. Patients with MPE frequently suffer from effusion related
      symptoms requiring therapeutic drainage. Conventionally, the options of therapeutic drainage
      of MPE include needle aspiration, and intercostal drain insertion with or without chemical
      pleurodesis. Needle aspiration allows quick relief of effusion and symptoms, though the
      volume of pleural effusion being aspirated with each attempt of needle puncture is limited to
      1-1.5 litres, and repeated puncture involves risks of complications. Intercostal drain
      insertion will allow gradual drainage of large pleural effusion over days, but the
      shortcomings being the long hospitalization of at least a week, and the presence of trapped
      lung would preclude chemical pleurodesis for definitive fluid control. Up to 40% of MPE
      patients still require repeated pleural drainage procedure, even after Talc chemical
      pleurodesis. The much longer hospitalization period is considered unfavourable for patients
      with limited lifespan in terms of weeks or a few months, who would spend more time with their
      family. In recent few years, indwelling pleural catheter (IPC) has provided a relatively
      novel option of palliative MPE drainage, on an ambulatory out-patient setting. IPC has been
      reported to be cost-effective, in particular for patients with survival of less than 14
      weeks. With the limited time span, it is important to balance between the aim of symptomatic
      relief and maintaining patient's quality of life. Invasive procedures and prolonged
      hospitalisation can cause great distress to patients. Predicted survival of patients with MPE
      would be important in informing the most suitable method for relieving MPE. Previous studies
      have identified relevant factors on prediction of survival in patients with malignant pleural
      effusion but so far, there is no data for Chinese patients. The LENT scoring system (pleural
      fluid lactate dehydrogenase, Eastern Cooperative Oncology Group performance score, neutrophil
      -to-lymphocyte ratio and tumour type) is a new validated prognostic score in malignant
      pleural effusion.
observational model: Cohort
time perspective: Prospective
measure: Further pleural intervention
time frame: 3 years
description: Rate of fluid recurrence requiring invasive pleural interventions
measure: Survival
time frame: 3 years
description: survival of lung cancer patient with malignant pleural effusion
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ka Yan Chiang, MBBS(HK)
role: Principal Investigator
affiliation: Queen Mary Hospital, Hong Kong
facility: 
country: Hong Kong
citation: Clive AO, Kahan BC, Hooper CE, Bhatnagar R, Morley AJ, Zahan-Evans N, Bintcliffe OJ, Boshuizen RC, Fysh ET, Tobin CL, Medford AR, Harvey JE, van den Heuvel MM, Lee YC, Maskell NA. Predicting survival in malignant pleural effusion: development and validation of the LENT prognostic score. Thorax. 2014 Dec;69(12):1098-104. doi: 10.1136/thoraxjnl-2014-205285. Epub 2014 Aug 6.
PMID: 25100651
citation: Anevlavis S, Kouliatsis G, Sotiriou I, Koukourakis MI, Archontogeorgis K, Karpathiou G, Giatromanolaki A, Froudarakis ME. Prognostic factors in patients presenting with pleural effusion revealing malignancy. Respiration. 2014;87(4):311-6. doi: 10.1159/000356764. Epub 2014 Jan 22.
PMID: 24457947
citation: Bielsa S, Salud A, Martinez M, Esquerda A, Martin A, Rodriguez-Panadero F, Porcel JM. Prognostic significance of pleural fluid data in patients with malignant effusion. Eur J Intern Med. 2008 Jul;19(5):334-9. doi: 10.1016/j.ejim.2007.09.014. Epub 2007 Nov 8.
PMID: 18549935
citation: Thomas R, Francis R, Davies HE, Lee YC. Interventional therapies for malignant pleural effusions: the present and the future. Respirology. 2014 Aug;19(6):809-22. doi: 10.1111/resp.12328. Epub 2014 Jun 19.
PMID: 24947955
citation: Lui MM, Fitzgerald DB, Lee YC. Phenotyping malignant pleural effusions. Curr Opin Pulm Med. 2016 Jul;22(4):350-5. doi: 10.1097/MCP.0000000000000267.
PMID: 27055073
citation: Davies HE, Mishra EK, Kahan BC, Wrightson JM, Stanton AE, Guhan A, Davies CW, Grayez J, Harrison R, Prasad A, Crosthwaite N, Lee YC, Davies RJ, Miller RF, Rahman NM. Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: the TIME2 randomized controlled trial. JAMA. 2012 Jun 13;307(22):2383-9. doi: 10.1001/jama.2012.5535.
PMID: 22610520
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Lui Mei Sze
investigator title: Doctor
mesh term: Lung Neoplasms
mesh term: Pleural Effusion, Malignant
mesh term: Pleural Effusion
sharing ipd: No
provided document: 