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

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Completed
• CT.gov ID: NCT05930626
• Collaborator: The Swedish Research Council (Other)
• Enrollment: 9,254
• Actual Duration (Months): 144

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Disease; Cardiovascular Diseases; Cancer; Environmental Exposure	Other: Biomarkers of acrylamide, glycidol, POPs, PFAS

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 9254 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Biomarkers of Acrylamide, Glycidol, POPs, PFAS and Disease Outcomes and OMICs Signatures
• Actual Study Start Date: Jan 1, 1997
• Actual Primary Completion Date: Dec 31, 2008
• Actual Study Completion Date: Dec 31, 2008

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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)

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Karolinska Institutet
• The Swedish Research Council

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Agneta Åkesson, Professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT05930626
• Other Study ID Numbers: EXP-21-CV8301-OMICS
• First Posted: Jul 5, 2023
• Last Update Posted: Jul 5, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Jul 5, 2023