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CompletedNCT03269656AGESUpdated Sep 1, 2017

Age Gene/Environment Susceptibility Reykjavik Study

An observational study in Neoplasms, sponsored by Icelandic Heart Association. Completed. Open to participants aged 66 Years to 98 Years. Per ClinicalTrials.gov, last updated 2017-09-01.

Sponsored by Icelandic Heart Association · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,764
Ages
66 Years to 98 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Neoplasms

Keywords

  • Vitamin D
  • Cancer
  • Survival
03

Who can participate

Ages eligible
66 Years to 98 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

In 1967, all 30,795 men and women living in the capital area of Iceland and born between 1907 and 1935 were invited by the Icelandic Heart Association to join a prospective cohort study. Approximately 19,000 attended the clinic at least once and became participants of the Reykjavik Study. Subsequently, in 2002, a random sample of the cohort comprising 5,764 men and women who were still alive in Iceland and aged 66 to 96 years entered the Ages Gene/Environment Susceptibility (AGES) - Reykjavik Study

Inclusion criteria

  • To participate in the AGES-Reykjavik study

Exclusion criteria

Exclusion Criteria:

  • To be diagnosed with cancer before study entry
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,764 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • AGES-Reykjavik participants

    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.

05

What researchers measure

Primary outcomes

  1. Overall survival

    The association between pre-diagnostic 25(OH)D levels in cancer patients and overall survival

    Time frame: From date of diagnosis until death or censored at end of the follow-up (December 31, 2014)

  2. Cancer survival

    The association between pre-diagnostic 25(OH)D levels in cancer patients and cancer survival

    Time frame: From date of diagnosis until cancer death or censored at the end of the follow-up (December 31, 2014)

Secondary outcomes

  1. Cancer diagnosis

    The association between pre-diagnostic 25(OH)D levels and cancer risk

    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

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 17351290 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03269656
Lead sponsor
Icelandic Heart Association
Collaborators
University of Iceland
Responsible party
Sponsor
First posted
Sep 1, 2017
Start date
Jan 1, 2002
Primary completion
Jan 31, 2006
Completion
Dec 31, 2014
Last update
Sep 1, 2017

Study contacts

Johanna Torfadottir, PhD
principal investigator · University of Iceland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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