<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/NCT03269656</url>
  </required_header>
  <id_info>
    <org_study_id>IHA</org_study_id>
    <secondary_id>NO1-AG-1-2100</secondary_id>
    <secondary_id>ZIAEY000401</secondary_id>
    <nct_id>NCT03269656</nct_id>
  </id_info>
  <brief_title>Age Gene/Environment Susceptibility Reykjavik Study</brief_title>
  <acronym>AGES</acronym>
  <official_title>Association of Pre-diagnostic Vitamin D Levels and Survival in Older Individuals With Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icelandic Heart Association</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Iceland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Icelandic Heart Association</source>
  <oversight_info>
    <has_dmc>No</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>
      5764 men and women in Iceland, aged 66 to 96 years entered the Ages Gene/Environment&#xD;
      Susceptibility (AGES) - Reykjavik Study. Serum 25(OH)D was measured in 5,519 of all 5,764&#xD;
      (96%) participants at study entry in year 2002 through 2006. The main emphasis was on&#xD;
      exploring whether pre-diagnostic serum levels of 25(OH)D were associated with survival after&#xD;
      cancer diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2002</start_date>
  <completion_date type="Actual">December 31, 2014</completion_date>
  <primary_completion_date type="Actual">January 31, 2006</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From date of diagnosis until death or censored at end of the follow-up (December 31, 2014)</time_frame>
    <description>The association between pre-diagnostic 25(OH)D levels in cancer patients and overall survival</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cancer survival</measure>
    <time_frame>From date of diagnosis until cancer death or censored at the end of the follow-up (December 31, 2014)</time_frame>
    <description>The association between pre-diagnostic 25(OH)D levels in cancer patients and cancer survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cancer diagnosis</measure>
    <time_frame>From date of blood draw (study entry) until cancer diagnosis, death or end of the observation period (December 31, 2014) whichever occurred first</time_frame>
    <description>The association between pre-diagnostic 25(OH)D levels and cancer risk</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">5764</enrollment>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>AGES-Reykjavik participants</arm_group_label>
    <description>Exploring whether pre-diagnostic serum levels of 25(OH)D among older individuals living in Iceland were associated with survival after cancer diagnosis. We also assessed the risk of being diagnosed with cancer in association with 25(OH)D levels.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        In 1967, all 30,795 men and women living in the capital area of Iceland and born between&#xD;
        1907 and 1935 were invited by the Icelandic Heart Association to join a prospective cohort&#xD;
        study. Approximately 19,000 attended the clinic at least once and became participants of&#xD;
        the Reykjavik Study. Subsequently, in 2002, a random sample of the cohort comprising 5,764&#xD;
        men and women who were still alive in Iceland and aged 66 to 96 years entered the Ages&#xD;
        Gene/Environment Susceptibility (AGES) - Reykjavik Study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To participate in the AGES-Reykjavik study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To be diagnosed with cancer before study entry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>66 Years</minimum_age>
    <maximum_age>98 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johanna Torfadottir, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iceland</affiliation>
  </overall_official>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2723948/</url>
    <description>Age, Gene/Environment Susceptibility-Reykjavik Study: Multidisciplinary Applied Phenomics</description>
  </link>
  <reference>
    <citation>Harris TB, Launer LJ, Eiriksdottir G, Kjartansson O, Jonsson PV, Sigurdsson G, Thorgeirsson G, Aspelund T, Garcia ME, Cotch MF, Hoffman HJ, Gudnason V. Age, Gene/Environment Susceptibility-Reykjavik Study: multidisciplinary applied phenomics. Am J Epidemiol. 2007 May 1;165(9):1076-87. doi: 10.1093/aje/kwk115. Epub 2007 Mar 10.</citation>
    <PMID>17351290</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vitamin D</keyword>
  <keyword>Cancer</keyword>
  <keyword>Survival</keyword>
  <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/NCT03269656
org study id: IHA
secondary id: NO1-AG-1-2100
secondary id: ZIAEY000401
nct id: NCT03269656
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
5764 men and women in Iceland, aged 66 to 96 years entered the Ages Gene/Environment
      Susceptibility (AGES) - Reykjavik Study. Serum 25(OH)D was measured in 5,519 of all 5,764
      (96%) participants at study entry in year 2002 through 2006. The main emphasis was on
      exploring whether pre-diagnostic serum levels of 25(OH)D were associated with survival after
      cancer diagnosis.
observational model: Cohort
time perspective: Prospective
measure: Overall survival
time frame: From date of diagnosis until death or censored at end of the follow-up (December 31, 2014)
description: The association between pre-diagnostic 25(OH)D levels in cancer patients and overall survival
measure: Cancer survival
time frame: From date of diagnosis until cancer death or censored at the end of the follow-up (December 31, 2014)
description: The association between pre-diagnostic 25(OH)D levels in cancer patients and cancer survival
measure: Cancer diagnosis
time frame: From date of blood draw (study entry) until cancer diagnosis, death or end of the observation period (December 31, 2014) whichever occurred first
description: The association between pre-diagnostic 25(OH)D levels and cancer risk
arm group label: AGES-Reykjavik participants
description: Exploring whether pre-diagnostic serum levels of 25(OH)D among older individuals living in Iceland were associated with survival after cancer diagnosis. We also assessed the risk of being diagnosed with cancer in association with 25(OH)D levels.
Serum samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 66 Years
maximum age: 98 Years
healthy volunteers: No
last name: Johanna Torfadottir, PhD
role: Principal Investigator
affiliation: University of Iceland
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2723948/
description: Age, Gene/Environment Susceptibility-Reykjavik Study: Multidisciplinary Applied Phenomics
citation: Harris TB, Launer LJ, Eiriksdottir G, Kjartansson O, Jonsson PV, Sigurdsson G, Thorgeirsson G, Aspelund T, Garcia ME, Cotch MF, Hoffman HJ, Gudnason V. Age, Gene/Environment Susceptibility-Reykjavik Study: multidisciplinary applied phenomics. Am J Epidemiol. 2007 May 1;165(9):1076-87. doi: 10.1093/aje/kwk115. Epub 2007 Mar 10.
PMID: 17351290
responsible party type: Sponsor
sharing ipd: Undecided