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

Completed

• Conditions: Disease; Environmental Exposure; Cardiovascular Diseases; Cancer
• Interventions: Other: Biomarkers of acrylamide, glycidol, POPs, PFAS

• Registration Number: NCT05930626
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-01-01
• Primary Completion: 2008-12-31
• Study Completion: 2008-12-31
• Status Verified: 2023-06
• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-30
• Last Update Submitted: 2023-06-30
• Study First Posted: 2023-07-05
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9254

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
60YO	Biomarkers of acrylamide, glycidol, POPs, PFAS	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.
SMC-C	Biomarkers of acrylamide, glycidol, POPs, PFAS	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.

Primary Outcome Measures

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