NeoplasmsAGESNCT03269656
Age Gene/Environment Susceptibility Reykjavik Study
An observational study of Neoplasms, run by Icelandic Heart Association.
Trial 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. Read more about this study
- Who is it for?
- Ages 66 to 98 years
- Conditions the study is for
- Neoplasms
- How many people
- 5,764 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2002to 31 Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 to 98 years
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- To participate in the AGES-Reykjavik study
Who cannot join
- To be diagnosed with cancer before study entry
About this study
Official title: 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.
- Conditions
- Neoplasms
- Keywords
- Vitamin D, Cancer, Survival
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The association between pre-diagnostic 25(OH)D levels in cancer patients and overall survival
Measured: From date of diagnosis until death or censored at end of the follow-up (December 31, 2014)
Cancer survival
The association between pre-diagnostic 25(OH)D levels in cancer patients and cancer survival
Measured: 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
Measured: From date of blood draw (study entry) until cancer diagnosis, death or end of the observation period (December 31, 2014) whichever occurred first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Jan 2002
- Primary completion31 Jan 2006
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,764 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icelandic Heart Association
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iceland
- Responsible party
- Sponsor
- Investigators
- Johanna Torfadottir, PhD, Principal investigator, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269656
- Sponsor's protocol ID
- IHA
- Other IDs
- NO1-AG-1-2100, ZIAEY000401
- Acronym
- AGES
- Status last verified
- Aug 2017
- First submitted
- 30 Aug 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Pre-diagnostic Vitamin D Levels and Survival in Older Individuals With Cancer
- ClinicalTrials.gov ID
- NCT03269656
- Acronym / sponsor ID
- AGES / IHA
- Conditions
- Neoplasms
- Keywords
- Vitamin D, Cancer, Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,764 participants (actual)
- Lead sponsor
- Icelandic Heart AssociationUniversity, hospital or other
- Collaborators
- University of Iceland
- Study start
- 1 Jan 2002 (actual)
- Primary completion
- 31 Jan 2006 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 66 to 98 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (1 listed)
- To participate in the AGES-Reykjavik study
Key exclusion criteria (1 listed)
- To be diagnosed with cancer before study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Background: PubMed 17351290Harris 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.
- Age, Gene/Environment Susceptibility-Reykjavik Study: Multidisciplinary Applied PhenomicsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johanna Torfadottir, PhD principal investigator
University of Iceland
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by Icelandic Heart Association.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From date of diagnosis until death or censored at end of the follow-up (December 31, 2014)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03269656, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.