<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/NCT03266887</url>
  </required_header>
  <id_info>
    <org_study_id>HI14010102</org_study_id>
    <nct_id>NCT03266887</nct_id>
  </id_info>
  <brief_title>Vitamin D Levels and Survival in Cancer Patients</brief_title>
  <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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Using the population-based data sources in Iceland and the well-characterized AGES-Reykjavik&#xD;
      cohort, our overarching aims are on exploring whether pre-diagnostic serum levels of&#xD;
      25-hydroxyvitamin D (25(OH)D) among older individuals living in Iceland were associated with&#xD;
      survival after cancer diagnosis. We also wanted to assess the risk of being diagnosed with&#xD;
      cancer in association with 25(OH)D levels. In this population living just south of the arctic&#xD;
      circle, vitamin D levels largely depend on dietary- and supplemental sources.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2002</start_date>
  <completion_date type="Actual">December 30, 2006</completion_date>
  <primary_completion_date type="Actual">December 30, 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 mortality among cancer patients</measure>
    <time_frame>Patients were followed from date of diagnosis since 2002 until death or censored at end of the follow-up (December 31, 2014)</time_frame>
    <description>We tested the association between pre-diagnostic 25(OH)D levels and total survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cancer-specific mortality among cancer patients</measure>
    <time_frame>Patients were followed from date of diagnosis since 2002 until death or censored at end of the follow-up (December 31, 2014)</time_frame>
    <description>We tested the association between pre-diagnostic 25(OH)D levels and cancer survival</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pre-diagnostic 25(OH)D levels and cancer risk</measure>
    <time_frame>Participants without cancer were followed from the study entry since 2002 until cancer diagnosis, death or end of the observation period whichever occurred first (December 31, 2014)</time_frame>
    <description>We tested the association between pre-diagnostic 25(OH)D levels and risk of being diagnosed with cancer</description>
  </other_outcome>
  <enrollment type="Actual">5764</enrollment>
  <condition>Neoplasms</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum&#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 (20). Serum 25(OH)D was measured&#xD;
        in 5,519 of all 5,764 (96%) participants at study entry in year 2002 through 2006.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be part of the AGES-Reykjavik Study, initiated between 2002 and 2006.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Diagnosed with cancer at 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>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed?term=American+journal+of+epidemiology%5BJour%5D+AND+Harris+TB%5Bfirst+author%5D+AND+Age%2C+Gene/Environment+Susceptibility%E2%80%93Reykjavik+Study%3A+Multidisciplinary+Applied+Phenomics&amp;TransSchema=title&amp;cmd=detailssearch</url>
    <description>Age, Gene/Environment Susceptibility-Reykjavik Study: Multidisciplinary Applied Phenomics</description>
  </link>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03266887
org study id: HI14010102
nct id: NCT03266887
lead sponsor: 
collaborator: 
has dmc: No
Using the population-based data sources in Iceland and the well-characterized AGES-Reykjavik
      cohort, our overarching aims are on exploring whether pre-diagnostic serum levels of
      25-hydroxyvitamin D (25(OH)D) among older individuals living in Iceland were associated with
      survival after cancer diagnosis. We also wanted to assess the risk of being diagnosed with
      cancer in association with 25(OH)D levels. In this population living just south of the arctic
      circle, vitamin D levels largely depend on dietary- and supplemental sources.
observational model: Cohort
time perspective: Prospective
measure: Overall mortality among cancer patients
time frame: Patients were followed from date of diagnosis since 2002 until death or censored at end of the follow-up (December 31, 2014)
description: We tested the association between pre-diagnostic 25(OH)D levels and total survival
measure: Cancer-specific mortality among cancer patients
time frame: Patients were followed from date of diagnosis since 2002 until death or censored at end of the follow-up (December 31, 2014)
description: We tested the association between pre-diagnostic 25(OH)D levels and cancer survival
measure: Pre-diagnostic 25(OH)D levels and cancer risk
time frame: Participants without cancer were followed from the study entry since 2002 until cancer diagnosis, death or end of the observation period whichever occurred first (December 31, 2014)
description: We tested the association between pre-diagnostic 25(OH)D levels and risk of being diagnosed with cancer
Serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 66 Years
maximum age: 98 Years
healthy volunteers: No
url: https://www.ncbi.nlm.nih.gov/pubmed?term=American+journal+of+epidemiology%5BJour%5D+AND+Harris+TB%5Bfirst+author%5D+AND+Age%2C+Gene/Environment+Susceptibility%E2%80%93Reykjavik+Study%3A+Multidisciplinary+Applied+Phenomics&TransSchema=title&cmd=detailssearch
description: Age, Gene/Environment Susceptibility-Reykjavik Study: Multidisciplinary Applied Phenomics
responsible party type: Sponsor