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Cohort of Swedish Men (COSM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01127711
Recruitment Status : Completed
First Posted : May 21, 2010
Last Update Posted : February 28, 2014
Sponsor:
Information provided by (Responsible Party):
Alicja Wolk, Karolinska Institutet

Tracking Information
First Submitted Date May 20, 2010
First Posted Date May 21, 2010
Last Update Posted Date February 28, 2014
Study Start Date September 1997
Actual Primary Completion Date December 1997   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 27, 2014)
  • Prostate cancer [ Time Frame: 1997-2010 ]
  • Pancreatic cancer [ Time Frame: 1997-2010 ]
  • Stomach cancer [ Time Frame: 1997-2010 ]
  • Cataract [ Time Frame: 1997-2010 ]
  • LUTS (Lower urinary tract symptom) [ Time Frame: 1997-2010 ]
  • Cardiovascular Diseases [ Time Frame: 1997-2010 ]
  • Mortality [ Time Frame: 1997-2010 ]
  • Colorectal Cancer [ Time Frame: 1997-2010 ]
  • Bladder cancer [ Time Frame: 1997-2010 ]
  • Fractures, hip fractures [ Time Frame: 1997-2014 ]
Original Primary Outcome Measures
 (submitted: May 20, 2010)
  • Prostate cancer [ Time Frame: 1997-2010 ]
  • Pancreatic cancer [ Time Frame: 1997-2010 ]
  • Stomach cancer [ Time Frame: 1997-2010 ]
  • Cataract [ Time Frame: 1997-2010 ]
  • LUTS (Lower urinary tract symptom) [ Time Frame: 1997-2010 ]
  • Cardiovascular Diseases [ Time Frame: 1997-2010 ]
  • Mortality [ Time Frame: 1997-2010 ]
  • Colorectal Cancer [ Time Frame: 1997-2010 ]
  • Bladder cancer [ Time Frame: 1997-2010 ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cohort of Swedish Men
Official Title Cohort of Swedish Men
Brief Summary The Cohort of Swedish Men began in 1997, when all men born between 1918 and 1952 and residing in two counties in central Sweden received a questionnaire including about 350 items concerning diet and other lifestyle factors. A second questionnaire was sent out in 2008-09.
Detailed Description

The Cohort of Swedish Men was established in 1997, when all men born between 1918 and 1952 and residing in Västmanland and Örebro counties in central Sweden received a questionnaire concerning diet and other lifestyle factors. Of the 100,303 eligible men, 48,850 (49%) responded to the questionnaire. The questionnaire included items about diet, physical activity, medical history, and lifestyle factors such as cigarette smoking history and use of dietary supplements.

During 2008-09, the exposure information was updated and extended by sending out two new questionnaires - one questionnaire on health including several signs of symptoms, sleeping, social relations etc (2008) and one on diet, dietary supplement use, and lifestyle factors (2009). Majority of questions in the questionnaires have been validated.

Incident cases of cancer are ascertained by record linkages of the study population with the National Swedish Cancer Register and the Regional Cancer Registers. Cardiovascular and other diseases as well as surgeries and causes of death are identified by linkage to the National Inpatient and other registries at the Swedish Board of Health and Welfare. Ascertainment of cancer cases and other diseases is almost 100% complete. Dates of deaths are ascertained through the Swedish Death Register (100% complete), and information on date of moving out of the study area is obtained by linkage with the Swedish Population Register.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Saliva Blood
Sampling Method Non-Probability Sample
Study Population Men born between 1918 and 1952, living in central Sweden (Örebro and Västmanlands counties)
Condition
  • Cancers
  • Cardiovascular Diseases
  • Cataract
  • Gastrointestinal Diseases
  • Osteoporosis
  • Fractures
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 20, 2010)
48850
Original Actual Enrollment Same as current
Study Completion Date Not Provided
Actual Primary Completion Date December 1997   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All men born between 1918 and 1952, living in central Sweden

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: Male
Ages 45 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01127711
Other Study ID Numbers 1706/2010-631-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Alicja Wolk, Karolinska Institutet
Study Sponsor Karolinska Institutet
Collaborators Not Provided
Investigators Not Provided
PRS Account Karolinska Institutet
Verification Date February 2014