<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/NCT01707758</url>
  </required_header>
  <id_info>
    <org_study_id>13421</org_study_id>
    <nct_id>NCT01707758</nct_id>
  </id_info>
  <brief_title>Detection of Cancer-Specific Active Proteases in Blood Via Fluorescence</brief_title>
  <official_title>Detection of Cancer-Specific Active Proteases in Blood Via Fluorescence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to develop a rapid in vitro screening assay for detection of&#xD;
      pancreatic cancer biomarkers in blood of patients with pancreatic cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of the project is to develop a rapid in vitro screening assay for detection of&#xD;
      cancer biomarkers in blood. The aim is testing and optimization of nanoparticle sensors,&#xD;
      based on cyanine dyes that are chemically linked to Fe/Fe3O4 nanoparticles via&#xD;
      protease-selective consensus (cleavage) sequences. The focus is on the quantitative&#xD;
      determination of active cancer-specific proteases in blood via simple fluorescence&#xD;
      measurements. The matrix metalloproteinases, urokinase-type plasminogen activator, and&#xD;
      cathepsins, are up-regulated in the vast majority of progressing cancers and can, therefore,&#xD;
      serve as markers for cell survival/tumor progression, angiogenesis, and tissue&#xD;
      remodeling/invasion&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Trial terminated - Nanoscale Company out of business&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>pancreatic cancer</arm_group_label>
    <description>This study will collect blood from 36 patients with known or suspected pancreatic cancer and from 12 healthy cancer-free subjects.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Approximately 1 tablespoon of blood will be collected from each subject.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be recruited from the University of Kansas Cancer Center prior to any&#xD;
        treatment for their pancreatic cancer. Final histology and staging will be recorded and&#xD;
        correlated with protease concnentration. Healthy subjects will be recruited from the&#xD;
        University of Kansas and Kansas State community.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion Criteria for Pancreatic Cancer Patients:&#xD;
&#xD;
          -  Patients will either have a histologic diagnosis of pancreatic carcinoma or a clinical&#xD;
             picture consistent with pancreatic cancer and will be undergoing surgery or a&#xD;
             diagnostic procedure to confirm the diagnosis.&#xD;
&#xD;
          -  Patients will have had no prior treatment or surgery&#xD;
&#xD;
        Inclusion Criteria for Healthy Subjects:&#xD;
&#xD;
          -  Subjects will have no prior history of any cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion Criteria for Pancreatic Cancer Patients&#xD;
&#xD;
          -  Any prior treatment for pancreatic cancer&#xD;
&#xD;
          -  Poorly controlled diabetes&#xD;
&#xD;
        Exclusion Criteria for Healthy Subjects&#xD;
&#xD;
          -  Poorly controlled diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen Williamson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center Cancer Center</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>May 15, 2013</last_update_submitted>
  <last_update_submitted_qc>May 15, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 16, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pancreatic cancer</keyword>
  <keyword>nanoparticle</keyword>
  <keyword>proteases</keyword>
  <keyword>cell survival</keyword>
  <keyword>tumor progression</keyword>
  <keyword>angiogenesis</keyword>
  <keyword>tissue remodeling/invasion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</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/NCT01707758
org study id: 13421
nct id: NCT01707758
lead sponsor: 
has dmc: Yes
The primary objective is to develop a rapid in vitro screening assay for detection of
      pancreatic cancer biomarkers in blood of patients with pancreatic cancer.
The goal of the project is to develop a rapid in vitro screening assay for detection of
      cancer biomarkers in blood. The aim is testing and optimization of nanoparticle sensors,
      based on cyanine dyes that are chemically linked to Fe/Fe3O4 nanoparticles via
      protease-selective consensus (cleavage) sequences. The focus is on the quantitative
      determination of active cancer-specific proteases in blood via simple fluorescence
      measurements. The matrix metalloproteinases, urokinase-type plasminogen activator, and
      cathepsins, are up-regulated in the vast majority of progressing cancers and can, therefore,
      serve as markers for cell survival/tumor progression, angiogenesis, and tissue
      remodeling/invasion
time perspective: Prospective
arm group label: pancreatic cancer
description: This study will collect blood from 36 patients with known or suspected pancreatic cancer and from 12 healthy cancer-free subjects.
Approximately 1 tablespoon of blood will be collected from each subject.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Stephen Williamson, MD
role: Principal Investigator
affiliation: University of Kansas Medical Center Cancer Center
country: United States
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms