<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/NCT02189434</url>
  </required_header>
  <id_info>
    <org_study_id>ERMC 14-14</org_study_id>
    <nct_id>NCT02189434</nct_id>
  </id_info>
  <brief_title>Does Serum Procalcitonin Levels Predict Sepsis in Patients Undergoing Cytoreductive Surgery</brief_title>
  <official_title>A Pilot Study to Determine the Correlation of Serum Procalcitonin Levels and Development of Sepsis in Patients Undergoing Cytoreductive Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eastern Regional Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eastern Regional Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Serum procalcitonin levels will be considerably higher, for a longer period of time, in&#xD;
      patients who develop sepsis compared to patients with SIRS or those who have an uncomplicated&#xD;
      post-surgical recovery. Monitoring of serum procalcitonin trends will allow for an earlier&#xD;
      diagnosis of, and initiation of treatment for, sepsis compared to current standard ICU&#xD;
      methods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 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>The primary objective of this study is to determine the natural progression of serum procalcitonin in patients recovering from cytoreductive surgery, with or without HIPEC.</measure>
    <time_frame>end of study</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Observe the patient's post-operative course with regards to serum procalcitonin levels and development of sepsis in patients previously treated with cytoreductive surgery with or without HIPEC.</measure>
    <time_frame>end of study</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Cytoreductive Surgery</condition>
  <arm_group>
    <arm_group_label>Cytoreductive surgery</arm_group_label>
    <description>Patients having undergone cytoreductive surgery with or without HIPEC will have serum procalcitonin lab draws</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Serum procalcitonin lab draws</intervention_name>
    <description>Blood will be collected in a 4mL capacity, green top lithium heparin tube. Samples can be drawn from a port with other labs. The samples will be centrifuged and then the plasma/serum will be removed and placed into a screw-capped round bottom plastic vial. Samples will be stored at -20○C until processing. Serum samples will be batch processed for each participant at the conclusion of their study period.&#xD;
These draws will be conducted for the sole purpose of this study, and whenever possible, they will be performed at the same time as routine blood draws conducted for medical monitoring to reduce the burden to the patients.</description>
    <arm_group_label>Cytoreductive surgery</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Collection of serum blood specimens&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Cancer patients having undergone cytoreductive surgery with or without HIPEC&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female or male person ≥ 18 years of age&#xD;
&#xD;
          -  Biopsy proven carcinoma&#xD;
&#xD;
          -  Scheduled for cytoreductive surgery, with or without HIPEC&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1, or 2&#xD;
&#xD;
          -  Able to give informed consent for protocol participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants are not able to understand or provide written informed consent&#xD;
&#xD;
          -  Pre-operative anti-inflammatory medication use within 72 hours of their baseline blood&#xD;
             draw&#xD;
&#xD;
          -  Pre-operative infection treatment with corticosteroids within 72 hours of their&#xD;
             baseline blood draw&#xD;
&#xD;
          -  Immunosuppressive illness other than neoplasm&#xD;
&#xD;
          -  Pregnant or lactating female&#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>Rod Flynn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eastern Regional Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eastern Regional Medical Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>July 10, 2017</last_update_submitted>
  <last_update_submitted_qc>July 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2017</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>Sepsis</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/NCT02189434
org study id: ERMC 14-14
nct id: NCT02189434
lead sponsor: 
has dmc: No
Serum procalcitonin levels will be considerably higher, for a longer period of time, in
      patients who develop sepsis compared to patients with SIRS or those who have an uncomplicated
      post-surgical recovery. Monitoring of serum procalcitonin trends will allow for an earlier
      diagnosis of, and initiation of treatment for, sepsis compared to current standard ICU
      methods.
observational model: Case-Only
time perspective: Prospective
measure: The primary objective of this study is to determine the natural progression of serum procalcitonin in patients recovering from cytoreductive surgery, with or without HIPEC.
time frame: end of study
measure: Observe the patient's post-operative course with regards to serum procalcitonin levels and development of sepsis in patients previously treated with cytoreductive surgery with or without HIPEC.
time frame: end of study
arm group label: Cytoreductive surgery
description: Patients having undergone cytoreductive surgery with or without HIPEC will have serum procalcitonin lab draws
intervention type: Other
intervention name: Serum procalcitonin lab draws
description: Blood will be collected in a 4mL capacity, green top lithium heparin tube. Samples can be drawn from a port with other labs. The samples will be centrifuged and then the plasma/serum will be removed and placed into a screw-capped round bottom plastic vial. Samples will be stored at -20○C until processing. Serum samples will be batch processed for each participant at the conclusion of their study period.
These draws will be conducted for the sole purpose of this study, and whenever possible, they will be performed at the same time as routine blood draws conducted for medical monitoring to reduce the burden to the patients.
arm group label: Cytoreductive surgery
Collection of serum blood specimens
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rod Flynn, MD
role: Principal Investigator
affiliation: Eastern Regional Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sepsis
sharing ipd: Undecided