Biological Signatures Resulting From Occupational Exposure to Complex Mixtures of PAHs

NCT05679544 | Recruiting

• 2 other identifiers: 38RC22.02192022-A01590-43
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This research project aims at better understanding the early biological effects resulting from occupational exposure to complex Polycyclic Aromatic Hydrocarbon (PAH) mixtures. Current biomarkers used as part of biomonitoring campaigns are biomarkers of exposure, not numerous and poorly related to health effects. The aim of this study is thus to improve our understanding of biological consequences of such exposures, both in terms of proteins deregulation, metabolism deregulation and genotoxicity.

Conditions

Metabolic Disturbance; Protein Deficiency; Genotoxicity

Keywords

polycyclic aromatic hydrocarbons; metabolism; mixtures; occupational exposure; genotoxicity

Outcome Measures

Primary Outcomes (3)

• Deregulation of blood proteins expression due to exposure to PAHs

  Number of proteins up or down regulated in period of exposure versus after holidays

  up to 6 months between both periods of study

• Deregulation of blood metabolites expression due to exposure to PAHs

  Number of metabolites up or down regulated in period of exposure versus after holidays

  up to 6 months between both periods of study

• Frequency of micronuclei measured due to exposure to PAHs

  Frequency of cells containing micronuclei in period of exposure versus after holidays

  up to 6 months between both periods of study

Study Arms (1)

Subjects occupationally exposed to PAHs

EXPERIMENTAL

Biological: Characterization of early biological effects following exposure to PAHs

Interventions

Characterization of early biological effects following exposure to PAHs BIOLOGICAL

Biological samples collected in period of exposure and after holidays

Subjects occupationally exposed to PAHs

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects ages 18 years or more
• Subjects occupationally exposed to PAHs since more than 3 months
• Having signed the informed consent
• recruited by the occupational health service

You may not qualify if:

• Obesity (BMI\>30)
• Subjects suffering cancers or metabolic diseases (diabetes, dyslipidemia, amino-acid diseases, renal or hepatic impairment) at the onset of the study.
• Subjects taking medications related to the above diseases at the onset of the study.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38043, France

RECRUITING

MeSH Terms

Conditions

Protein Deficiency

Condition Hierarchy (Ancestors)

Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Renaud PERSOONS

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renaud PERSOONS, PhD, Pharm D

CONTACT

00 33 4 76 76 51 78; RPersoons@chu-grenoble.fr

Christine DEMEILLIERS, PhD

CONTACT

00 33 4 76 63 75 01; christine.demeilliers@univ-grenoble-alpes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 11, 2023
• Study Start: April 25, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)