<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/NCT01675258</url>
  </required_header>
  <id_info>
    <org_study_id>LSA003-HMO-CTIL</org_study_id>
    <nct_id>NCT01675258</nct_id>
  </id_info>
  <brief_title>Identifying Saliva Markers of Patients With Stomach, Colorectal (Including Pre-cancer Polyp) and Pancreatic Cancers</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hadassah Medical Organization</source>
  <brief_summary>
    <textblock>
      Colorectal cancers account for 783,000 new cases and cause 437,000 deaths per year across the&#xD;
      world. Diagnosis in the early stages improves survival rates. Up to now, these cancers are&#xD;
      mostly diagnosed only at later stages of the disease's course through histoimmune staining&#xD;
      and molecular biology processes on the tissues biopsied from the gastrointestinal system&#xD;
      under invasive diagnostic procedures of colonoscopy.&#xD;
&#xD;
      Oral fluid presents a large protein complexity and has been recently used as a diagnostic&#xD;
      biofluid for oral, as well as systematic diseases. Using oral fluid as a bio-marker for the&#xD;
      colorectal cancer can be advantageous as it contains gastrointestinal fluids, in addition to&#xD;
      bacteria and bacteria lysate, which can also serve as a bio-markers' source for colorectal&#xD;
      cancers. Proteomic technologies provide the tools needed to discover and identify&#xD;
      disease-associated biomarkers.&#xD;
&#xD;
      The aim of the present study is to identify salivary bio-markers in patients suffering from&#xD;
      colorectal cancers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <primary_completion_date type="Anticipated">September 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Gastric Cancer</condition>
  <condition>Colorectal Cancer and Pre-cancer Polyps</condition>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Healthy adults above the age of 18 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study</arm_group_label>
    <description>Adult patients above the age of 18 years with gastric, colorectal (including pre-cancer polyps) or pancreatic cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Salivary samples</intervention_name>
    <description>Each participant will give a sample of saliva through spitting for 10 minutes in a sterile tube.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Study</arm_group_label>
    <other_name>Salivary Analysis</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole saliva&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients identified with gastric, colorectal (including pre-cancer polyps) or pancreatic&#xD;
        cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has not yet started treatment for the identified cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  medically compromised patients&#xD;
&#xD;
          -  congenital syndromes&#xD;
&#xD;
          -  being treated with radiotherapy or chemotherapy.&#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>Moti Moskovitz, DMD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hadassah Medical Organization</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eyal Shtayer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hadassah Medical Organization</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Avi Levin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hadassah Medical Organization</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hadassah Medical Organization</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Hadas Lemberg, PhD</last_name>
      <phone>0097226777572</phone>
      <email>lhadas@hadassah.org.il</email>
    </contact>
    <investigator>
      <last_name>Moti Moskovitz, DMD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <results_reference>
    <citation>Zhang L, Farrell JJ, Zhou H, Elashoff D, Akin D, Park NH, Chia D, Wong DT. Salivary transcriptomic biomarkers for detection of resectable pancreatic cancer. Gastroenterology. 2010 Mar;138(3):949-57.e1-7. doi: 10.1053/j.gastro.2009.11.010. Epub 2009 Nov 18.</citation>
    <PMID>19931263</PMID>
  </results_reference>
  <verification_date>July 2012</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>August 27, 2012</last_update_submitted>
  <last_update_submitted_qc>August 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2012</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>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Polyps</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/NCT01675258
org study id: LSA003-HMO-CTIL
nct id: NCT01675258
lead sponsor: 
Colorectal cancers account for 783,000 new cases and cause 437,000 deaths per year across the
      world. Diagnosis in the early stages improves survival rates. Up to now, these cancers are
      mostly diagnosed only at later stages of the disease's course through histoimmune staining
      and molecular biology processes on the tissues biopsied from the gastrointestinal system
      under invasive diagnostic procedures of colonoscopy.

      Oral fluid presents a large protein complexity and has been recently used as a diagnostic
      biofluid for oral, as well as systematic diseases. Using oral fluid as a bio-marker for the
      colorectal cancer can be advantageous as it contains gastrointestinal fluids, in addition to
      bacteria and bacteria lysate, which can also serve as a bio-markers' source for colorectal
      cancers. Proteomic technologies provide the tools needed to discover and identify
      disease-associated biomarkers.

      The aim of the present study is to identify salivary bio-markers in patients suffering from
      colorectal cancers.
observational model: Case-Control
time perspective: Cross-Sectional
arm group label: Control
description: Healthy adults above the age of 18 years
arm group label: Study
description: Adult patients above the age of 18 years with gastric, colorectal (including pre-cancer polyps) or pancreatic cancer
intervention type: Other
intervention name: Salivary samples
description: Each participant will give a sample of saliva through spitting for 10 minutes in a sterile tube.
arm group label: Control
arm group label: Study
other name: Salivary Analysis
whole saliva
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Moti Moskovitz, DMD, PhD
role: Principal Investigator
affiliation: Hadassah Medical Organization
last name: Eyal Shtayer, MD
role: Principal Investigator
affiliation: Hadassah Medical Organization
last name: Avi Levin, MD
role: Principal Investigator
affiliation: Hadassah Medical Organization
facility: 
contact: 
investigator: 
country: Israel
citation: Zhang L, Farrell JJ, Zhou H, Elashoff D, Akin D, Park NH, Chia D, Wong DT. Salivary transcriptomic biomarkers for detection of resectable pancreatic cancer. Gastroenterology. 2010 Mar;138(3):949-57.e1-7. doi: 10.1053/j.gastro.2009.11.010. Epub 2009 Nov 18.
PMID: 19931263
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Polyps