Swedish Mammography Cohort

Cardiovascular Diseases Clinical Trial

— SMC  

Official title:

Swedish Mammography Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127698
• Other study ID #: 1706/2010-631-1
• Status: Completed
• Phase: N/A
• First received: May 20, 2010
• Last updated: February 27, 2014
• Start date: March 1987

Study information

• Verified date: February 2014
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Ethical Rewiev BoardSweden: The Swedish Data Inspection Board
• Study type: Observational

Clinical Trial Summary

The Swedish Mammography Cohort began in 1987-1990, when 66,651 women living in two counties in central Sweden completed a mailed questionnaire that included items about their diet, parity, age at first child's birth, history of breast cancer in family, weight, height, and education. Follow-up questionnaires have been sent out in 1997 and in 2008-09.

Description:

From 1987 to 1990 a population-based mammography screening program was introduced in two counties in central Sweden. In Västmanland County all women born between 1917 and 1948 received a mailed invitation to be screened by mammography between March 1987 and March 1989 (n=41,786) together with a 6-page questionnaire; 31,735 women (76%) returned the completed questionnaires. In Uppsala County all women born between 1914 and 1948 were invited to the screening and received the same questionnaire between January 1988 and December 1990 (n=48517); 34916 women (72%) returned the completed questionnaires. Hence, questionnaires completed before undergoing mammography were obtained from 66,651 women (74%) in the source population. These questionnaires included items about diet, parity, age at first child's birth, history of breast cancer in family, weight, height, and education.

In 1997 a second questionnaire was sent to all cohort members who were still living in the study area. The questionnaire updated information about diet and was extended to include information on physical activity, medical history, age at menarche, history of oral contraceptive use, age at menopause, postmenopausal hormone use and lifestyle factors such as cigarette smoking history and use of dietary supplements. Majority of questions in the questionnaires have been validated.

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61433
• Est. primary completion date: December 1990
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 74 Years

Eligibility

Inclusion Criteria:

• All women born between 1914 and 1948, living in central Sweden

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancers
• Cardiovascular Diseases
• Cataract
• Digestive System Diseases
• Fractures
• Gastrointestinal Diseases
• Osteoporosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Harvard School of Public Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast cancer		1987-2010	No
Primary	Colorectal cancer		1987-2010	No
Primary	Endometrial Cancer		1987-2010	No
Primary	Ovarian cancer		1987-2010	No
Primary	Pancreatic cancer		1987-2010	No
Primary	Stomach cancer		1987-2010	No
Primary	Kidney cancer		1987-2010	No
Primary	Bladder cancer		1987-2010	No
Primary	Cardiovascular diseases		1987-2010	No
Primary	Mortality		1987-2010	No
Primary	Cataract		1987-2010	No
Primary	Fractures, hip fractures		1987-2014	No

External Links

•   Unit of Nutritional Epidemiology