<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/NCT03250637</url>
  </required_header>
  <id_info>
    <org_study_id>19-TLR</org_study_id>
    <nct_id>NCT03250637</nct_id>
  </id_info>
  <brief_title>Diet, Genes and Colorectal Cancer - With Focus on Toll-like Receptor Polymorphisms</brief_title>
  <official_title>Meat and Fiber Intake and Interaction With Pattern Recognition Receptors (TLR1, TLR2, TLR4, and TLR10) in Relation to Colorectal Cancer in a Danish Prospective, Case-cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Danish Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the interaction between diet - primary meat and fiber&#xD;
      - and polymorphisms in Toll-like receptors in relation to risk of colorectal cancer in a&#xD;
      Danish prospective cohort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Meat and dietary fibers have been associated with increased and decreased risk of colorectal&#xD;
      cancer (CRC), respectively. Toll-like receptors (TLRs) regulate intestinal immune response in&#xD;
      a complex interplay between the mucosal epithelium and the microbiota and may therefore be&#xD;
      important modulators of diet-induced CRC and interact with other inflammatory mediators.&#xD;
&#xD;
      The aim of the study is to investigate the association with functional TLR polymorphisms in&#xD;
      relation to risk of CRC and their interaction with dietary factors. Additionally,&#xD;
      interactions with previously studied polymorphisms in IL10, IL1B, PTGS2 and NFKB1 will be&#xD;
      assessed in order to examine possible biological pathways in meat-induced CRC.&#xD;
&#xD;
      Data are retrieved from the Danish prospective &quot;Diet, Cancer and Health&quot; study encompassing&#xD;
      57,053 persons which were recruited between 1993 to 1997. Between 1994 and 31th December&#xD;
      2009, 1038 CRC cases has been diagnosed. A sub-cohort of 1857 persons has been randomly&#xD;
      selected within the full cohort at time of entry into the cohort. The study design is a&#xD;
      nested case-cohort study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1993</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">May 1997</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Colorectal cancer</measure>
    <time_frame>Between 1994 and 31th December 2009</time_frame>
    <description>Follow-up was based on population-based cancer registries</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2895</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Colorectal cancer cases</arm_group_label>
    <description>1038 participants diagnosed with colorectal cancer from the Diet, Cancer and Health cohort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sub-cohort members</arm_group_label>
    <description>1857 persons randomly selected within the full cohort at time of entry into the Diet, Cancer and Health cohort. These participants serve as controls for the colorectal cancer cases.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational</intervention_name>
    <description>Information on diet, lifestyle, weight, height, medical treatment, environmental exposures, and other socio-economic factors were collected at enrolment using questionnaires and interviews</description>
    <arm_group_label>Colorectal cancer cases</arm_group_label>
    <arm_group_label>Sub-cohort members</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      DNA extracted from buffy coeats&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The Diet, Cancer and Health study is an ongoing Danish cohort study designed to investigate&#xD;
        the relation between diet, lifestyle and cancer risk. The cohort consists of 57,053&#xD;
        persons, recruited between December 1993 and May 1997. All the subjects were born in&#xD;
        Denmark, and the individuals were 50 to 64 years of age and had no previous cancers at&#xD;
        study entry. Blood samples, anthropometric measures and questionnaire data on diet and&#xD;
        lifestyle were collected at study entry.&#xD;
&#xD;
        The present study uses a nested case-cohort design. Follow-up is based on population-based&#xD;
        cancer registries. Between 1994 and 31th December 2009, 1038 CRC cases were diagnosed. A&#xD;
        sub-cohort of 1857 persons has randomly been selected within the full cohort at time of&#xD;
        entry into the cohort.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Born in Denmark and had no previous cancers at study entry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous or present cancer(s) at study entry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Vibeke Andersen, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Southern Denmark</affiliation>
  </overall_official>
  <reference>
    <citation>Tjonneland A, Olsen A, Boll K, Stripp C, Christensen J, Engholm G, Overvad K. Study design, exposure variables, and socioeconomic determinants of participation in Diet, Cancer and Health: a population-based prospective cohort study of 57,053 men and women in Denmark. Scand J Public Health. 2007;35(4):432-41. doi: 10.1080/14034940601047986.</citation>
    <PMID>17786808</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Vibeke Andersen</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Gene-environment interaction</keyword>
  <keyword>Candidate gene</keyword>
  <keyword>Western style diet</keyword>
  <keyword>Toll-like receptors</keyword>
  <keyword>Prospective study</keyword>
  <keyword>Nested case-cohort</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03250637
org study id: 19-TLR
nct id: NCT03250637
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the interaction between diet - primary meat and fiber
      - and polymorphisms in Toll-like receptors in relation to risk of colorectal cancer in a
      Danish prospective cohort.
Meat and dietary fibers have been associated with increased and decreased risk of colorectal
      cancer (CRC), respectively. Toll-like receptors (TLRs) regulate intestinal immune response in
      a complex interplay between the mucosal epithelium and the microbiota and may therefore be
      important modulators of diet-induced CRC and interact with other inflammatory mediators.

      The aim of the study is to investigate the association with functional TLR polymorphisms in
      relation to risk of CRC and their interaction with dietary factors. Additionally,
      interactions with previously studied polymorphisms in IL10, IL1B, PTGS2 and NFKB1 will be
      assessed in order to examine possible biological pathways in meat-induced CRC.

      Data are retrieved from the Danish prospective "Diet, Cancer and Health" study encompassing
      57,053 persons which were recruited between 1993 to 1997. Between 1994 and 31th December
      2009, 1038 CRC cases has been diagnosed. A sub-cohort of 1857 persons has been randomly
      selected within the full cohort at time of entry into the cohort. The study design is a
      nested case-cohort study.
observational model: Other
time perspective: Prospective
measure: Colorectal cancer
time frame: Between 1994 and 31th December 2009
description: Follow-up was based on population-based cancer registries
arm group label: Colorectal cancer cases
description: 1038 participants diagnosed with colorectal cancer from the Diet, Cancer and Health cohort.
arm group label: Sub-cohort members
description: 1857 persons randomly selected within the full cohort at time of entry into the Diet, Cancer and Health cohort. These participants serve as controls for the colorectal cancer cases.
intervention type: Other
intervention name: Observational
description: Information on diet, lifestyle, weight, height, medical treatment, environmental exposures, and other socio-economic factors were collected at enrolment using questionnaires and interviews
arm group label: Colorectal cancer cases
arm group label: Sub-cohort members
DNA extracted from buffy coeats
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 64 Years
last name: Vibeke Andersen, MD, PhD
role: Study Director
affiliation: University of Southern Denmark
citation: Tjonneland A, Olsen A, Boll K, Stripp C, Christensen J, Engholm G, Overvad K. Study design, exposure variables, and socioeconomic determinants of participation in Diet, Cancer and Health: a population-based prospective cohort study of 57,053 men and women in Denmark. Scand J Public Health. 2007;35(4):432-41. doi: 10.1080/14034940601047986.
PMID: 17786808
responsible party type: Principal Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Vibeke Andersen
investigator title: Clinical Professor
mesh term: Colorectal Neoplasms
sharing ipd: No