<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/NCT02247297</url>
  </required_header>
  <id_info>
    <org_study_id>KEK-ZH-Nr. 2014-0046</org_study_id>
    <nct_id>NCT02247297</nct_id>
  </id_info>
  <brief_title>Pancreatic Stone Protein (PSP) in Pregnant Women</brief_title>
  <official_title>Analysis of Serum Pancreatic Stone Protein (PSP) in Healthy Pregnant Women and Its Value in Predicting Inflammatory Complications During Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nicole Ochsenbein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective, single centred cohort study evaluates the physiological course of the&#xD;
      potentially novel biomarker PSP in pregnant women as well as its predictive role in the&#xD;
      development of inflammatory complications during pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pregnant women feature a complex immunological condition caused by pregnancy itself and hence&#xD;
      women present with an increased susceptibility to some infectious and non-infectious&#xD;
      inflammatory diseases. Specifically regulated mechanisms have been described occurring in&#xD;
      normal whereas lacking in pathological pregnancies in both the native and adaptive immune&#xD;
      system in animal models and humans. However, clinically relevant biomarker associated with&#xD;
      preterm premature rupture of membranes (PPROM), amniotic infection syndrome (AIS) as well as&#xD;
      pregnancy associated complications such as preeclampsia and hemolysis, elevated liver&#xD;
      enzymes, and low platelets (HELLP) syndrome have their limitations.&#xD;
&#xD;
      Pancreatic stone protein (PSP), originally obtained from human pancreatic stones from&#xD;
      patients operated for chronic calcifying pancreatitis, has been studied in several&#xD;
      gastrointestinal pathologies.&#xD;
&#xD;
      The aim of this study is to evaluate the physiological course of the potentially novel&#xD;
      biomarker PSP in pregnant women as well as to assess its predictive role in the development&#xD;
      of inflammatory complications during pregnancy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Physiological course of PSP in healthy pregnant women</measure>
    <time_frame>34 weeks</time_frame>
    <description>Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Predictive role of PSP in the development of complications during pregnancy</measure>
    <time_frame>34 weeks</time_frame>
    <description>Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">486</enrollment>
  <condition>Pregnancy</condition>
  <condition>HELLP Syndrome</condition>
  <condition>Preterm Premature Rupture of Fetal Membranes</condition>
  <condition>Preeclampsia</condition>
  <arm_group>
    <arm_group_label>Pregnant Women</arm_group_label>
    <description>Healthy pregnant women and women with preeclampsia, HELLP syndrom, amniotic infection syndrome, or preterm premature rupture of membranes</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood collection</intervention_name>
    <description>Diagnostic blood collection</description>
    <arm_group_label>Pregnant Women</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women (healthy or with preeclampsia, HELLP syndrome, amniotic infection syndrome,&#xD;
        or PPROM)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Healthy women with single pregnancy&#xD;
&#xD;
          -  Women with PPROM, AIS, preeclampsia, or HELLP syndrome&#xD;
&#xD;
          -  Patients able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Viral (hepatitis B virus, hepatitis C virus, human immunodeficiency virus) or&#xD;
             confirmed bacterial infections&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicole Ochsenbein, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicole Ochsenbein, Prof. Dr.</last_name>
    <phone>+41 (0)44 255 11 11</phone>
    <email>nicole.ochsenbein@usz.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nora Gadient, Dr. med.</last_name>
    <phone>+41 (0)44 255 11 11</phone>
    <email>nora.gadient@usz.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicole Ochsenbein, Prof. Dr.</last_name>
      <phone>+41 (0) 44 255 11 11</phone>
      <email>nicole.ochsenbein@usz.ch</email>
    </contact>
    <contact_backup>
      <last_name>Nora Gadient, Dr. med.</last_name>
      <phone>+41 (0) 44 255 11 11</phone>
      <email>nora.gadient@usz.ch</email>
    </contact_backup>
    <investigator>
      <last_name>Franziska Krähenmann, Dr. med.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Roland Zimmermann, Prof. Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rolf Graf, Prof. Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Perparim Limani, Dr. med.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://www.geburtshilfe.usz.ch</url>
    <description>Department of Obstetrics, University Hospital Zurich</description>
  </link>
  <link>
    <url>http://www.vis.usz.ch</url>
    <description>Department of Surgery, Swiss Hepatopancreatobiliary (HPB) Laboratory, University Hospital Zurich</description>
  </link>
  <results_reference>
    <citation>De Caro A, Lohse J, Sarles H. Characterization of a protein isolated from pancreatic calculi of men suffering from chronic calcifying pancreatitis. Biochem Biophys Res Commun. 1979 Apr 27;87(4):1176-82. doi: 10.1016/s0006-291x(79)80031-5. No abstract available.</citation>
    <PMID>111670</PMID>
  </results_reference>
  <results_reference>
    <citation>Graf R, Schiesser M, Reding T, Appenzeller P, Sun LK, Fortunato F, Perren A, Bimmler D. Exocrine meets endocrine: pancreatic stone protein and regenerating protein--two sides of the same coin. J Surg Res. 2006 Jun 15;133(2):113-20. doi: 10.1016/j.jss.2005.09.030. Epub 2005 Dec 19.</citation>
    <PMID>16360171</PMID>
  </results_reference>
  <results_reference>
    <citation>Keel M, Harter L, Reding T, Sun LK, Hersberger M, Seifert B, Bimmler D, Graf R. Pancreatic stone protein is highly increased during posttraumatic sepsis and activates neutrophil granulocytes. Crit Care Med. 2009 May;37(5):1642-8. doi: 10.1097/CCM.0b013e31819da7d6.</citation>
    <PMID>19325491</PMID>
  </results_reference>
  <results_reference>
    <citation>Boeck L, Graf R, Eggimann P, Pargger H, Raptis DA, Smyrnios N, Thakkar N, Siegemund M, Rakic J, Tamm M, Stolz D. Pancreatic stone protein: a marker of organ failure and outcome in ventilator-associated pneumonia. Chest. 2011 Oct;140(4):925-932. doi: 10.1378/chest.11-0018. Epub 2011 Aug 11.</citation>
    <PMID>21835904</PMID>
  </results_reference>
  <results_reference>
    <citation>Que YA, Delodder F, Guessous I, Graf R, Bain M, Calandra T, Liaudet L, Eggimann P. Pancreatic stone protein as an early biomarker predicting mortality in a prospective cohort of patients with sepsis requiring ICU management. Crit Care. 2012 Jul 2;16(4):R114. doi: 10.1186/cc11406.</citation>
    <PMID>22748193</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>November 23, 2018</last_update_submitted>
  <last_update_submitted_qc>November 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Zurich</investigator_affiliation>
    <investigator_full_name>Nicole Ochsenbein</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </responsible_party>
  <keyword>Pancreatic stone protein (PSP)</keyword>
  <keyword>premature rupture of membranes (PPROM)</keyword>
  <keyword>amniotic infection syndrome (AIS)</keyword>
  <keyword>hemolysis, elevated liver enzymes, and low platelets (HELLP)</keyword>
  <keyword>preeclampsia</keyword>
  <keyword>pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>HELLP Syndrome</mesh_term>
    <mesh_term>Fetal Membranes, Premature Rupture</mesh_term>
    <mesh_term>Rupture</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/NCT02247297
org study id: KEK-ZH-Nr. 2014-0046
nct id: NCT02247297
lead sponsor: 
collaborator: 
has dmc: No
This prospective, single centred cohort study evaluates the physiological course of the
      potentially novel biomarker PSP in pregnant women as well as its predictive role in the
      development of inflammatory complications during pregnancy.
Pregnant women feature a complex immunological condition caused by pregnancy itself and hence
      women present with an increased susceptibility to some infectious and non-infectious
      inflammatory diseases. Specifically regulated mechanisms have been described occurring in
      normal whereas lacking in pathological pregnancies in both the native and adaptive immune
      system in animal models and humans. However, clinically relevant biomarker associated with
      preterm premature rupture of membranes (PPROM), amniotic infection syndrome (AIS) as well as
      pregnancy associated complications such as preeclampsia and hemolysis, elevated liver
      enzymes, and low platelets (HELLP) syndrome have their limitations.

      Pancreatic stone protein (PSP), originally obtained from human pancreatic stones from
      patients operated for chronic calcifying pancreatitis, has been studied in several
      gastrointestinal pathologies.

      The aim of this study is to evaluate the physiological course of the potentially novel
      biomarker PSP in pregnant women as well as to assess its predictive role in the development
      of inflammatory complications during pregnancy.
observational model: Cohort
time perspective: Prospective
measure: Physiological course of PSP in healthy pregnant women
time frame: 34 weeks
description: Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)
measure: Predictive role of PSP in the development of complications during pregnancy
time frame: 34 weeks
description: Measurement of serum PSP through ELISA (Enzyme Linked Immunosorbent Assay)
arm group label: Pregnant Women
description: Healthy pregnant women and women with preeclampsia, HELLP syndrom, amniotic infection syndrome, or preterm premature rupture of membranes
intervention type: Procedure
intervention name: Blood collection
description: Diagnostic blood collection
arm group label: Pregnant Women
Serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicole Ochsenbein, Prof. Dr.
role: Principal Investigator
affiliation: University of Zurich
last name: Nicole Ochsenbein, Prof. Dr.
phone: +41 (0)44 255 11 11
email: nicole.ochsenbein@usz.ch
last name: Nora Gadient, Dr. med.
phone: +41 (0)44 255 11 11
email: nora.gadient@usz.ch
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Switzerland
url: http://www.geburtshilfe.usz.ch
description: Department of Obstetrics, University Hospital Zurich
url: http://www.vis.usz.ch
description: Department of Surgery, Swiss Hepatopancreatobiliary (HPB) Laboratory, University Hospital Zurich
citation: De Caro A, Lohse J, Sarles H. Characterization of a protein isolated from pancreatic calculi of men suffering from chronic calcifying pancreatitis. Biochem Biophys Res Commun. 1979 Apr 27;87(4):1176-82. doi: 10.1016/s0006-291x(79)80031-5. No abstract available.
PMID: 111670
citation: Graf R, Schiesser M, Reding T, Appenzeller P, Sun LK, Fortunato F, Perren A, Bimmler D. Exocrine meets endocrine: pancreatic stone protein and regenerating protein--two sides of the same coin. J Surg Res. 2006 Jun 15;133(2):113-20. doi: 10.1016/j.jss.2005.09.030. Epub 2005 Dec 19.
PMID: 16360171
citation: Keel M, Harter L, Reding T, Sun LK, Hersberger M, Seifert B, Bimmler D, Graf R. Pancreatic stone protein is highly increased during posttraumatic sepsis and activates neutrophil granulocytes. Crit Care Med. 2009 May;37(5):1642-8. doi: 10.1097/CCM.0b013e31819da7d6.
PMID: 19325491
citation: Boeck L, Graf R, Eggimann P, Pargger H, Raptis DA, Smyrnios N, Thakkar N, Siegemund M, Rakic J, Tamm M, Stolz D. Pancreatic stone protein: a marker of organ failure and outcome in ventilator-associated pneumonia. Chest. 2011 Oct;140(4):925-932. doi: 10.1378/chest.11-0018. Epub 2011 Aug 11.
PMID: 21835904
citation: Que YA, Delodder F, Guessous I, Graf R, Bain M, Calandra T, Liaudet L, Eggimann P. Pancreatic stone protein as an early biomarker predicting mortality in a prospective cohort of patients with sepsis requiring ICU management. Crit Care. 2012 Jul 2;16(4):R114. doi: 10.1186/cc11406.
PMID: 22748193
responsible party type: Sponsor-Investigator
investigator affiliation: University of Zurich
investigator full name: Nicole Ochsenbein
investigator title: Prof. Dr. med.
mesh term: Pre-Eclampsia
mesh term: HELLP Syndrome
mesh term: Fetal Membranes, Premature Rupture
mesh term: Rupture