NCT02765529

Brief Summary

Nowadays, an increase of inflammatory chronic diseases and/or tumors incidence has been reported in part due to the rising in life expectancy. For instance, exposure to air pollution, and in particularly to fine particles has been classified by the International Agency for Research on Cancer (IARC) as a risk factor for cancer, being the elderly population particularly sensitive. However, no validated biomarkers have been identified to assess the exposure to fine particles maybe correlated to cancerogenesis. AEROTOX-2 is a prospective pilot study on the ex vivo effects of the atmospheric pollution exposure. The study aims to identity new biomarkers after an exposure of leukocytes to doses of fine particles. Secondly, the study aims to analyze, according to age, the leukocytes response to the urban pollution exposure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

April 25, 2016

Last Update Submit

April 15, 2026

Conditions

Biomarkers of Air Pollution Exposure

Keywords

Environmental PollutionFine particlesBiomarkersElderly

Outcome Measures

Primary Outcomes (1)

  • Level of expression of blood biomarkers of air pollution exposure

    These markers will be searched in association with the different mechanisms involved in the toxicity of the fine particles such as: inflammatory response, genotoxicity, metabolic activity and epigenetic changes after exposure of leukocytes to doses of fine particles.

    through the study completion, an average of 48 months

Secondary Outcomes (9)

  • Total amount of different populations of peripheral blood leucocytes

    through the study completion, an average of 48 months

  • Measure of the expression of genes involved in metabolism by quantitative polymerase chain reaction (qPCR)

    through the study completion, an average of 48 months

  • Measure of the expression of genes involved in metabolism by TaqMan Gene Expression Assays

    through the study completion, an average of 48 months

  • Detection of genotoxicity by identification of DNA double-strand breaks and DNA adducts

    through the study completion, an average of 48 months

  • Detection of epigenetic modifications

    through the study completion, an average of 48 months

  • +4 more secondary outcomes

Study Arms (4)

20-30 years

EXPERIMENTAL

Blood sampling

Procedure: Blood sampling

45-55 years

EXPERIMENTAL

Blood sampling

Procedure: Blood sampling

70-80 years

EXPERIMENTAL

Blood sampling

Procedure: Blood sampling

Control

EXPERIMENTAL

Blood sampling for standardization of technical procedures

Procedure: Blood sampling

Interventions

Blood samplingPROCEDURE
20-30 years45-55 years70-80 yearsControl

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 20-30 years, 45-55 years or 70-80 years
  • Signature of an informed consent
  • Non-smoker or ex-smoker for more than 10 years
  • Homogeneous repartition between men and women
  • Social insurance affiliation
  • Understanding or being able to speak French

You may not qualify if:

  • Pregnant or breast feeding woman
  • Occupational exposure (metallurgy, petrochemistry, house painter) for more than 10 years and having ceased all activities in these areas for less than 10 years ago.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Center Naturalpha

Lille, Hauts-de-France, 59000, France

Location

Related Publications (1)

  • Fougere B, Landkocz Y, Lepers C, Martin PJ, Armand L, Grossin N, Verdin A, Boulanger E, Gosset P, Sichel F, Shirali P, Billet S. Influence of aging in the modulation of epigenetic biomarkers of carcinogenesis after exposure to air pollution. Exp Gerontol. 2018 Sep;110:125-132. doi: 10.1016/j.exger.2018.05.018. Epub 2018 May 31.

    PMID: 29860068RESULT

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Gosset Pierre, MD

    Lille Catholic University

    PRINCIPAL INVESTIGATOR

  • Sylvain Billet

    UCEIV

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2016

First Posted

May 6, 2016

Study Start

November 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)