Biomarkers of Acrylamide, Glycidol, POPs, PFAS and Disease Outcomes and OMICs Signatures

The aim of the project is to assess the associations between biomarkers of acrylamide and glycidol exposure and disease outcomes in a case-cohort study based on two prospective cohorts with biobanks. The investigators also aim to assess the exposure-affected OMICS signatures and molecular pathways underlying disease development (specifically cardiovascular diseases such as myocardial infarction and stroke and cancer such as breast-, endometrial and colorectal cancer) for these exposures along with persistent organic pollutants (POPs) and per- and polyflouroalkyl substances (PFAS) using a prospective cohort study utilizing and integrating various 'OMICs' technologies.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Disease; Cancer; Environmental Exposure
• Intervention / Treatment: Other: Biomarkers of acrylamide, glycidol, POPs, PFAS

• Study Type: Observational
• Enrollment (Actual): 9254

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

60YO: Men and women of 60 years of age living in Stockholm SMC-C: Women living in Uppsala

Description

Inclusion Criteria:

• 60YO: Men and women of 60 years old residing in Stockholm
• SMC-C: Women residing in Uppsala

Exclusion Criteria:

• Subjects will be excluded if they had the outcome under investigation at baseline

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SMC-C; Swedish Mammography Cohort-clinical (SMC-C) is a clinical sub-cohort established between 2003 and 2008, consisting of 5022 women, 56-80 years of age, living in Uppsala. These women have completed a detailed questionnaire on diet and lifestyle factors and underwent a health examination, dual-energy X-ray absorptiometry and biological sampling.	Other: Biomarkers of acrylamide, glycidol, POPs, PFAS; These are food contaminants (acrylamide, glycidol) and environmental pollutants (POPs, PFAS). Assess the associations between biomarkers of acrylamide and glycidol exposure and disease outcomes in a case-cohort study based on two prospective cohorts with biobanks. The investigators also aim to assess the exposure-affected OMICS signatures and molecular pathways underlying disease development (specifically cardiovascular diseases such as myocardial infarction and stroke and cancer such as breast-, endometrial and colorectal cancer) for these exposures along with POPs and PFAS using a prospective cohort study utilizing and integrating various 'OMICs' technologies.
60YO; The cohort of 60-years olds (60YO) was established with the aim to study CVD etiology and consists of 4,232 men and women aged 60 years who were randomly selected from Stockholm County and with baseline examination during 1 year in 1997-98. The study participants underwent a health examination, completed a questionnaire, and donated blood samples.	Other: Biomarkers of acrylamide, glycidol, POPs, PFAS; These are food contaminants (acrylamide, glycidol) and environmental pollutants (POPs, PFAS). Assess the associations between biomarkers of acrylamide and glycidol exposure and disease outcomes in a case-cohort study based on two prospective cohorts with biobanks. The investigators also aim to assess the exposure-affected OMICS signatures and molecular pathways underlying disease development (specifically cardiovascular diseases such as myocardial infarction and stroke and cancer such as breast-, endometrial and colorectal cancer) for these exposures along with POPs and PFAS using a prospective cohort study utilizing and integrating various 'OMICs' technologies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular disease	Using International Classification of Diseases (ICD) codes to assess cardiovascular disease (CVD) incidence (myocardial infarction and stroke, ICD10: I21 and I63)	From baseline beginning in 2003 through 2017
Cancer	Using ICD codes to assess cancer (such as ICD-10: C18, C20, C50, C54)	From baseline (2003 for SMC-C and 1997 for 60YO) until the latest available follow-up, currently 2021

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: The Swedish Research Council

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 1997
• Primary Completion (Actual): December 31, 2008
• Study Completion (Actual): December 31, 2008

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: EXP-21-CV8301-OMICS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data is available from registers at Statistics Sweden and National Board of Health and Welfare in Sweden.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No