AzTrials
AzTrials

CancersSMCNCT01127698

Swedish Mammography Cohort

An observational study of Cancers and Cardiovascular Diseases, run by Karolinska Institutet.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 74 years, women only
Conditions the study is for
Cancers, Cardiovascular Diseases, Cataract
How many people
61,433 participants
Where
No sites listed yet
Study dates
Mar 1987to Dec 1990
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 40 to 74 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Women born between 1914 and 1948, living in central Sweden (Uppsala and Västmanlands counties)

Who may be able to join

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

Who cannot join

  • None

About this study

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.

Read the detailed 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.

Medical subject headings
Neoplasms, Cardiovascular Diseases, Cataract, Gastrointestinal Diseases, Osteoporosis, Fractures, Bone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breast cancer

    Measured: 1987-2010

  2. Colorectal cancer

    Measured: 1987-2010

  3. Endometrial Cancer

    Measured: 1987-2010

  4. Ovarian cancer

    Measured: 1987-2010

  5. Pancreatic cancer

    Measured: 1987-2010

  6. Stomach cancer

    Measured: 1987-2010

  7. Kidney cancer

    Measured: 1987-2010

  8. Bladder cancer

    Measured: 1987-2010

  9. Cardiovascular diseases

    Measured: 1987-2010

  10. Mortality

    Measured: 1987-2010

  11. Cataract

    Measured: 1987-2010

  12. Fractures, hip fractures

    Measured: 1987-2014

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2010 (estimated)
  2. Study startMar 1987
  3. Primary completionDec 1990

Resources

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
61,433 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01127698
Sponsor's protocol ID
1706/2010-631-1
Acronym
SMC
Status last verified
Feb 2014
First submitted
20 May 2010
Last updated
28 Feb 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Larsson SC, Drca N, Bjorck M, Back M, Wolk A. Nut consumption and incidence of seven cardiovascular diseases. Heart. 2018 Oct;104(19):1615-1620. doi: 10.1136/heartjnl-2017-312819. Epub 2018 Apr 16.

    PubMed 29661934

  • Larsson SC, Wallin A, Hakansson N, Stackelberg O, Back M, Wolk A. Type 1 and type 2 diabetes mellitus and incidence of seven cardiovascular diseases. Int J Cardiol. 2018 Jul 1;262:66-70. doi: 10.1016/j.ijcard.2018.03.099. Epub 2018 Mar 24.

    PubMed 29605469

  • Roze JC, Ancel PY, Lepage P, Martin-Marchand L, Al Nabhani Z, Delannoy J, Picaud JC, Lapillonne A, Aires J, Durox M, Darmaun D, Neu J, Butel MJ; Nutrition EPIPAGE 2 study group; EPIFLORE Study Group. Nutritional strategies and gut microbiota composition as risk factors for necrotizing enterocolitis in very-preterm infants. Am J Clin Nutr. 2017 Sep;106(3):821-830. doi: 10.3945/ajcn.117.152967. Epub 2017 Jun 28.

    PubMed 28659297

  • Larsson SC, Wolk A. Potato consumption and risk of cardiovascular disease: 2 prospective cohort studies. Am J Clin Nutr. 2016 Nov;104(5):1245-1252. doi: 10.3945/ajcn.116.142422. Epub 2016 Sep 28.

    PubMed 27680993

  • Bellavia A, Stilling F, Wolk A. High red meat intake and all-cause cardiovascular and cancer mortality: is the risk modified by fruit and vegetable intake? Am J Clin Nutr. 2016 Oct;104(4):1137-1143. doi: 10.3945/ajcn.116.135335. Epub 2016 Aug 24.

    PubMed 27557655

  • Xu H, Akesson A, Orsini N, Hakansson N, Wolk A, Carrero JJ. Modest U-Shaped Association between Dietary Acid Load and Risk of All-Cause and Cardiovascular Mortality in Adults. J Nutr. 2016 Aug;146(8):1580-5. doi: 10.3945/jn.116.231019. Epub 2016 Jul 6.

    PubMed 27385761

  • Larsson SC, Tektonidis TG, Gigante B, Akesson A, Wolk A. Healthy Lifestyle and Risk of Heart Failure: Results From 2 Prospective Cohort Studies. Circ Heart Fail. 2016 Apr;9(4):e002855. doi: 10.1161/CIRCHEARTFAILURE.115.002855.

    PubMed 27072861

  • Larsson SC, Wallin A, Wolk A. Dietary Approaches to Stop Hypertension Diet and Incidence of Stroke: Results From 2 Prospective Cohorts. Stroke. 2016 Apr;47(4):986-90. doi: 10.1161/STROKEAHA.116.012675. Epub 2016 Feb 11.

    PubMed 26869384

  • Larsson SC, Hakansson N, Wolk A. Dietary cysteine and other amino acids and stroke incidence in women. Stroke. 2015 Apr;46(4):922-6. doi: 10.1161/STROKEAHA.114.008022. Epub 2015 Feb 10.

    PubMed 25669310

  • Oskarsson V, Orsini N, Sadr-Azodi O, Wolk A. Fish consumption and risk of non-gallstone-related acute pancreatitis: a prospective cohort study. Am J Clin Nutr. 2015 Jan;101(1):72-8. doi: 10.3945/ajcn.113.076174. Epub 2014 Nov 5.

    PubMed 25527752

  • Bellavia A, Larsson SC, Bottai M, Wolk A, Orsini N. Differences in survival associated with processed and with nonprocessed red meat consumption. Am J Clin Nutr. 2014 Sep;100(3):924-9. doi: 10.3945/ajcn.114.086249. Epub 2014 Jul 16.

    PubMed 25030780

  • Bellavia A, Larsson SC, Bottai M, Wolk A, Orsini N. Fruit and vegetable consumption and all-cause mortality: a dose-response analysis. Am J Clin Nutr. 2013 Aug;98(2):454-9. doi: 10.3945/ajcn.112.056119. Epub 2013 Jun 26.

    PubMed 23803880

  • Genkinger JM, Friberg E, Goldbohm RA, Wolk A. Long-term dietary heme iron and red meat intake in relation to endometrial cancer risk. Am J Clin Nutr. 2012 Oct;96(4):848-54. doi: 10.3945/ajcn.112.039537. Epub 2012 Sep 5.

    PubMed 22952183

  • Larsson SC, Virtamo J, Wolk A. Fish consumption and risk of stroke in Swedish women. Am J Clin Nutr. 2011 Mar;93(3):487-93. doi: 10.3945/ajcn.110.002287. Epub 2010 Dec 29.

    PubMed 21191140

Questions about this trial

What is this clinical trial studying?

An observational study of Cancers and Cardiovascular Diseases, run by Karolinska Institutet.

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 28 Feb 2014. 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?

Breast cancer (time frame: 1987-2010). The study lists 12 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 NCT01127698, which also lists 14 linked publications.

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 28 Feb 2014.

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