<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/NCT03303833</url>
  </required_header>
  <id_info>
    <org_study_id>CMO 2005-283</org_study_id>
    <secondary_id>2014/1184</secondary_id>
    <secondary_id>2005-3275 / 2007-3842</secondary_id>
    <secondary_id>CP2013-58</secondary_id>
    <nct_id>NCT03303833</nct_id>
  </id_info>
  <brief_title>The GEOLynch Cohort Study</brief_title>
  <acronym>GEOLynch</acronym>
  <official_title>The GEOLynch Cohort Study: Genetic, Environmental and Other Factors That Influence Tumour Risk Among Persons With Lynch Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wageningen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wereld Kanker Onderzoek Fonds</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dutch Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Funding: Biobanking and BioMolecular resources Research Infrastructure The Netherlands</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wageningen University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The GEOLynch cohort study has been established to investigate the influence of genetic,&#xD;
      environmental and other factors on tumour risk in persons with Lynch syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The GEOLynch cohort study includes persons with Lynch syndrome (LS) only. Persons with LS&#xD;
      carry an inherited mutation in one of the DNA mismatch repair genes MLH1, MSH2, MSH6 or PMS2&#xD;
      which increases their risk of several types of cancer, especially colorectal and endometrial&#xD;
      cancer. Additionally, mutations in the EPCAM gene that result in epigenetic silencing of the&#xD;
      MSH2 gene cause LS. Since 2006, persons with LS are invited to participate in the GEOLynch&#xD;
      cohort study via the Netherlands Foundation for the Detection of Hereditary Tumours, the&#xD;
      Radboud University Medical Center Nijmegen or the University Medical Centre Groningen.&#xD;
      Moreover, persons with LS can participate in the study after contacting the researcher&#xD;
      themselves. Participants are asked to complete a food frequency questionnaire and&#xD;
      questionnaires about dietary supplement use, physical activity, weight, height and medication&#xD;
      use. A buccal swab was asked of every participant recruited between 2006 and 2008. From 2012&#xD;
      on, newly recruited participants are asked to donate a blood sample instead of a buccal swab.&#xD;
      Furthermore, participants who had been recruited between 2006 and 2008 were asked to complete&#xD;
      the questionnaires again and to donate a blood sample too. Hence, follow-up measurements are&#xD;
      available for a subset of participants. DNA has been subtracted from the buccal swabs to&#xD;
      genotype SNPs of the IGF gene axis and polymorphisms of MTHFR C377T. Blood samples are&#xD;
      biobanked to facilitate future analyses of biomarkers, nutrients, DNA etc. Clinical&#xD;
      characteristics regarding performed colonoscopies and tumour diagnoses of all participants is&#xD;
      gathered from medical records and a linkage to the nationwide network and registry of histo-&#xD;
      and cytopathology in the Netherlands (PALGA Foundation ). Hazard ratios will be calculated to&#xD;
      investigate the influence of genetic, environmental and other factor on tumour risk. Repeated&#xD;
      measures analyses will be used if follow-up measurements are taken into account.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2006</start_date>
  <completion_date type="Anticipated">December 2030</completion_date>
  <primary_completion_date type="Anticipated">December 2030</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Colorectal tumour diagnoses</measure>
    <time_frame>Diagnoses before and after study inclusion will be assessed approximately every 2 years until study completion by regularly reviewing medical reports and/or pathology reports.</time_frame>
    <description>All diagnosed colorectal adenomas and carcinomas described in paticipants' medical reports and/or pathology reports.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endometrial cancer diagnoses</measure>
    <time_frame>Diagnoses before and after study inclusion will be assessed approximately every 2 years until study completion by regularly reviewing medical reports and/or pathology reports.</time_frame>
    <description>All diagnosed endometrial cancers described in participants' medical reports and/or pathology reports.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall cancer diagnoses</measure>
    <time_frame>Diagnoses before and after study inclusion will be assessed approximately every 2 years until study completion by regularly reviewing medical reports and/or pathology reports.</time_frame>
    <description>All diagnosed cancer types described in participants' medical reports and/or pathology reports.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Lynch Syndrome</condition>
  <condition>Neoplasms</condition>
  <condition>Hereditary Nonpolyposis Colorectal Cancer</condition>
  <condition>Colorectal Neoplasms</condition>
  <arm_group>
    <arm_group_label>Persons with Lynch syndrome</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention, observational study.</intervention_name>
    <arm_group_label>Persons with Lynch syndrome</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Buccal swabs and blood samples.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Men and women aged 18 to 80 years with Lynch syndrome who do or do not have a (previous)&#xD;
        cancer diagnosis.&#xD;
      </textblock>
    </study_pop>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persons with a known mutation in a gene that causes Lynch syndrome, i.e. with an&#xD;
             inherited monoallelic pathogenic germline mutation in either the MLH1, MSH2, MSH6,&#xD;
             PMS2 or EPCAM gene.&#xD;
&#xD;
          -  Aged between 18 and 80 years at inclusion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Additional carrier of another hereditary colon cancer predisposition syndrome (e.g.&#xD;
             FAP)&#xD;
&#xD;
          -  (Chronic) Inflammatory bowel disease&#xD;
&#xD;
          -  Non-Dutch speaking&#xD;
&#xD;
          -  Dementia or another mental condition that makes it impossible to fill out&#xD;
             questionnaires&#xD;
&#xD;
          -  Terminally ill persons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ellen Kampman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wageningen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fränzel van Duijnhoven, PhD</last_name>
    <phone>+31 317 485 375</phone>
    <email>franzel.vanduijnhoven@wur.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Wageningen University</name>
      <address>
        <city>Wageningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fränzel van Duijnhoven, PhD</last_name>
      <phone>+31 317 485 375</phone>
      <email>franzel.vanduijnhoven@wur.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>http://www.geolynch-studie.nl/geolynchstudy_eng</url>
    <description>GEOLynch website</description>
  </link>
  <reference>
    <citation>van Duijnhoven FJ, Botma A, Winkels R, Nagengast FM, Vasen HF, Kampman E. Do lifestyle factors influence colorectal cancer risk in Lynch syndrome? Fam Cancer. 2013 Jun;12(2):285-93. doi: 10.1007/s10689-013-9645-8.</citation>
    <PMID>23657759</PMID>
  </reference>
  <results_reference>
    <citation>Jung AY, van Duijnhoven FJ, Nagengast FM, Botma A, Heine-Broring RC, Kleibeuker JH, Vasen HF, Harryvan JL, Winkels RM, Kampman E. Dietary B vitamin and methionine intake and MTHFR C677T genotype on risk of colorectal tumors in Lynch syndrome: the GEOLynch cohort study. Cancer Causes Control. 2014 Sep;25(9):1119-29. doi: 10.1007/s10552-014-0412-4. Epub 2014 Jun 12.</citation>
    <PMID>24916333</PMID>
  </results_reference>
  <results_reference>
    <citation>Botma A, Nagengast FM, Braem MG, Hendriks JC, Kleibeuker JH, Vasen HF, Kampman E. Body mass index increases risk of colorectal adenomas in men with Lynch syndrome: the GEOLynch cohort study. J Clin Oncol. 2010 Oct 1;28(28):4346-53. doi: 10.1200/JCO.2010.28.0453. Epub 2010 Aug 23.</citation>
    <PMID>20733131</PMID>
  </results_reference>
  <results_reference>
    <citation>Winkels RM, Botma A, Van Duijnhoven FJ, Nagengast FM, Kleibeuker JH, Vasen HF, Kampman E. Smoking increases the risk for colorectal adenomas in patients with Lynch syndrome. Gastroenterology. 2012 Feb;142(2):241-7. doi: 10.1053/j.gastro.2011.10.033. Epub 2011 Nov 4.</citation>
    <PMID>22062356</PMID>
  </results_reference>
  <results_reference>
    <citation>Botma A, Vasen HF, van Duijnhoven FJ, Kleibeuker JH, Nagengast FM, Kampman E. Dietary patterns and colorectal adenomas in Lynch syndrome: the GEOLynch cohort study. Cancer. 2013 Feb 1;119(3):512-21. doi: 10.1002/cncr.27726. Epub 2012 Dec 17. Erratum In: Cancer. 2013 Jun 15;119(12):2358.</citation>
    <PMID>23254892</PMID>
  </results_reference>
  <results_reference>
    <citation>Heine-Broring RC, Winkels RM, Botma A, van Duijnhoven FJ, Jung AY, Kleibeuker JH, Nagengast FM, Vasen HF, Kampman E. Dietary Supplement Use and Colorectal Adenoma Risk in Individuals with Lynch Syndrome: The GEOLynch Cohort Study. PLoS One. 2013 Jun 18;8(6):e66819. doi: 10.1371/journal.pone.0066819. Print 2013.</citation>
    <PMID>23825568</PMID>
  </results_reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>October 5, 2017</last_update_submitted>
  <last_update_submitted_qc>October 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lifestyle</keyword>
  <keyword>Nutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms, Hereditary Nonpolyposis</mesh_term>
    <mesh_term>Syndrome</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/NCT03303833
org study id: CMO 2005-283
secondary id: 2014/1184
secondary id: 2005-3275 / 2007-3842
secondary id: CP2013-58
nct id: NCT03303833
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The GEOLynch cohort study has been established to investigate the influence of genetic,
      environmental and other factors on tumour risk in persons with Lynch syndrome.
The GEOLynch cohort study includes persons with Lynch syndrome (LS) only. Persons with LS
      carry an inherited mutation in one of the DNA mismatch repair genes MLH1, MSH2, MSH6 or PMS2
      which increases their risk of several types of cancer, especially colorectal and endometrial
      cancer. Additionally, mutations in the EPCAM gene that result in epigenetic silencing of the
      MSH2 gene cause LS. Since 2006, persons with LS are invited to participate in the GEOLynch
      cohort study via the Netherlands Foundation for the Detection of Hereditary Tumours, the
      Radboud University Medical Center Nijmegen or the University Medical Centre Groningen.
      Moreover, persons with LS can participate in the study after contacting the researcher
      themselves. Participants are asked to complete a food frequency questionnaire and
      questionnaires about dietary supplement use, physical activity, weight, height and medication
      use. A buccal swab was asked of every participant recruited between 2006 and 2008. From 2012
      on, newly recruited participants are asked to donate a blood sample instead of a buccal swab.
      Furthermore, participants who had been recruited between 2006 and 2008 were asked to complete
      the questionnaires again and to donate a blood sample too. Hence, follow-up measurements are
      available for a subset of participants. DNA has been subtracted from the buccal swabs to
      genotype SNPs of the IGF gene axis and polymorphisms of MTHFR C377T. Blood samples are
      biobanked to facilitate future analyses of biomarkers, nutrients, DNA etc. Clinical
      characteristics regarding performed colonoscopies and tumour diagnoses of all participants is
      gathered from medical records and a linkage to the nationwide network and registry of histo-
      and cytopathology in the Netherlands (PALGA Foundation ). Hazard ratios will be calculated to
      investigate the influence of genetic, environmental and other factor on tumour risk. Repeated
      measures analyses will be used if follow-up measurements are taken into account.
observational model: Cohort
time perspective: Other
measure: Colorectal tumour diagnoses
time frame: Diagnoses before and after study inclusion will be assessed approximately every 2 years until study completion by regularly reviewing medical reports and/or pathology reports.
description: All diagnosed colorectal adenomas and carcinomas described in paticipants' medical reports and/or pathology reports.
measure: Endometrial cancer diagnoses
time frame: Diagnoses before and after study inclusion will be assessed approximately every 2 years until study completion by regularly reviewing medical reports and/or pathology reports.
description: All diagnosed endometrial cancers described in participants' medical reports and/or pathology reports.
measure: Overall cancer diagnoses
time frame: Diagnoses before and after study inclusion will be assessed approximately every 2 years until study completion by regularly reviewing medical reports and/or pathology reports.
description: All diagnosed cancer types described in participants' medical reports and/or pathology reports.
arm group label: Persons with Lynch syndrome
intervention type: Other
intervention name: No intervention, observational study.
arm group label: Persons with Lynch syndrome
Buccal swabs and blood samples.
study pop: 
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ellen Kampman, PhD
role: Principal Investigator
affiliation: Wageningen University
last name: Fränzel van Duijnhoven, PhD
phone: +31 317 485 375
email: franzel.vanduijnhoven@wur.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
url: http://www.geolynch-studie.nl/geolynchstudy_eng
description: GEOLynch website
citation: van Duijnhoven FJ, Botma A, Winkels R, Nagengast FM, Vasen HF, Kampman E. Do lifestyle factors influence colorectal cancer risk in Lynch syndrome? Fam Cancer. 2013 Jun;12(2):285-93. doi: 10.1007/s10689-013-9645-8.
PMID: 23657759
citation: Jung AY, van Duijnhoven FJ, Nagengast FM, Botma A, Heine-Broring RC, Kleibeuker JH, Vasen HF, Harryvan JL, Winkels RM, Kampman E. Dietary B vitamin and methionine intake and MTHFR C677T genotype on risk of colorectal tumors in Lynch syndrome: the GEOLynch cohort study. Cancer Causes Control. 2014 Sep;25(9):1119-29. doi: 10.1007/s10552-014-0412-4. Epub 2014 Jun 12.
PMID: 24916333
citation: Botma A, Nagengast FM, Braem MG, Hendriks JC, Kleibeuker JH, Vasen HF, Kampman E. Body mass index increases risk of colorectal adenomas in men with Lynch syndrome: the GEOLynch cohort study. J Clin Oncol. 2010 Oct 1;28(28):4346-53. doi: 10.1200/JCO.2010.28.0453. Epub 2010 Aug 23.
PMID: 20733131
citation: Winkels RM, Botma A, Van Duijnhoven FJ, Nagengast FM, Kleibeuker JH, Vasen HF, Kampman E. Smoking increases the risk for colorectal adenomas in patients with Lynch syndrome. Gastroenterology. 2012 Feb;142(2):241-7. doi: 10.1053/j.gastro.2011.10.033. Epub 2011 Nov 4.
PMID: 22062356
citation: Botma A, Vasen HF, van Duijnhoven FJ, Kleibeuker JH, Nagengast FM, Kampman E. Dietary patterns and colorectal adenomas in Lynch syndrome: the GEOLynch cohort study. Cancer. 2013 Feb 1;119(3):512-21. doi: 10.1002/cncr.27726. Epub 2012 Dec 17. Erratum In: Cancer. 2013 Jun 15;119(12):2358.
PMID: 23254892
citation: Heine-Broring RC, Winkels RM, Botma A, van Duijnhoven FJ, Jung AY, Kleibeuker JH, Nagengast FM, Vasen HF, Kampman E. Dietary Supplement Use and Colorectal Adenoma Risk in Individuals with Lynch Syndrome: The GEOLynch Cohort Study. PLoS One. 2013 Jun 18;8(6):e66819. doi: 10.1371/journal.pone.0066819. Print 2013.
PMID: 23825568
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Colorectal Neoplasms
mesh term: Colorectal Neoplasms, Hereditary Nonpolyposis
mesh term: Syndrome