Age Gene/Environment Susceptibility Reykjavik Study (AGES)

August 30, 2017 updated by: Icelandic Heart Association

Association of Pre-diagnostic Vitamin D Levels and Survival in Older Individuals With Cancer

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

5764

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years to 98 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • To participate in the AGES-Reykjavik study

Exclusion Criteria:

  • To be diagnosed with cancer before study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of diagnosis until death or censored at end of the follow-up (December 31, 2014)
The association between pre-diagnostic 25(OH)D levels in cancer patients and overall survival
From date of diagnosis until death or censored at end of the follow-up (December 31, 2014)
Cancer survival
Time Frame: From date of diagnosis until cancer death or censored at the end of the follow-up (December 31, 2014)
The association between pre-diagnostic 25(OH)D levels in cancer patients and cancer survival
From date of diagnosis until cancer death or censored at the end of the follow-up (December 31, 2014)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The association between pre-diagnostic 25(OH)D levels and cancer risk
From date of blood draw (study entry) until cancer diagnosis, death or end of the observation period (December 31, 2014) whichever occurred first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icelandic Heart Association

Collaborators

University of Iceland

Investigators

  • Principal Investigator: Johanna Torfadottir, PhD, University of Iceland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2002

Primary Completion (Actual)

January 31, 2006

Study Completion (Actual)

December 31, 2014

Study Registration Dates

First Submitted

August 30, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

September 1, 2017

Study Record Updates

Last Update Posted (Actual)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 30, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IHA
  • NO1-AG-1-2100 (Other Grant/Funding Number: National Institute on Aging)
  • ZIAEY000401 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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