A Multinational, Observational Follow-Up Study of the Incidence of Cancer and Mortality in Patients From the SEAS Trial
45 Years
85 Years
Both
Cancer
Trial Information
A Multinational, Observational Follow-Up Study of the Incidence of Cancer and Mortality in Patients From the SEAS Trial
The SEAS Follow-up Study is a 21 month extension to the base protocol (2004_050,
MK0653A-043; NCT00092677). The main objective of the extension is to observe the incidence
rates of cancer, total mortality, and mortality due to cancer over a 21 month follow-up
period (from 04-March 2008 to 31-December 2009) in patients from the SEAS clinical trial.
The sources of study data will include data collected from national cancer and death
registries as well as data from the original clinical trial. No patient visits will occur.
National cancer and death registries exist in 5 of the 7 countries that participated in the
base SEAS trial. Registries do not exist in Ireland and Germany. As a result, data will be
collected only for all SEAS patients known to be alive at the end of the base study
originating from Sweden, Denmark, Norway, Finland, and the United Kingdom.
Inclusion Criteria:
- The cohort will include all patients from the five participating countries (Sweden,
Denmark, Norway, Finland, and United Kingdom) who were randomized into the SEAS base
study and who were known to be alive at the end of the base study
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
New Incidence of Cancer
Outcome Time Frame:
21 Months after the end of the base study
Safety Issue:
Yes
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
Denmark: Danish Medicines Agency
Study ID:
MK-0653A-043-10
NCT ID:
NCT01077830
Start Date:
March 2010
Completion Date:
March 2013
Related Keywords:
- Cancer
- New Incidence of Cancer
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