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

NCT05930626 | Completed

• 1 other identifier: EXP-21-CV8301-OMICS
• Study Type: observational
• Target: 9,254
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Disease; Cardiovascular Diseases; Cancer; Environmental Exposure

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

Biomarkers of acrylamide, glycidol, POPs, PFAS OTHER

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; SMC-C

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• The Swedish Research Council: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Disease; Cardiovascular Diseases; Neoplasms

Interventions

glycidol; phosphoribosylformylglycinamidine synthetase

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: July 5, 2023
• Study Start: January 1, 1997
• Primary Completion: December 31, 2008
• Study Completion: December 31, 2008
• Last Updated: July 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share