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NCT05930626 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05930626
Other study ID # EXP-21-CV8301-OMICS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 1997
Est. completion date December 31, 2008

Study information
Verified date June 2023
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 9254
Est. completion date December 31, 2008
Est. primary completion date December 31, 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Karolinska Institutet The Swedish Research Council

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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