Exposure to Chemical Substances Within Household Waste In... | NCT06183866

Studies
Exposure to Chemical Substances Within Household Waste Incineration Plants

NCT06183866

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Dec 28, 2023Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Exposure to Chemical Pollution, Occupational

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2022Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Dec 16, 2022

First Submission Date that Met QC Criteria

Dec 13, 2023

First Posted Date

Dec 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2023

Last Update Posted Date

Dec 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Employees of household waste incineration plants (UIOM) are exposed to multiple chemical substances that can pose a risk to their health.

The studies carried out find increases in certain toxic chemicals (heavy metals, dioxins), in the biological fluids of employees (blood, urine), in particular before the 2000s Another study conducted by Tait finds potential organic alterations.The investigators wish to complete the dissertation work with, in particular, an analysis of the quantitative elements of the exposure assessment (metrologies and biometrologies)

Detailed Description

The aim of the study is to evaluate the recorded chemical exposures of certain employees of a household waste incineration plant (UIOM) in order to deduce the risk to their health.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retrospective evaluation of the identified chemical exposures of certain employees of a household waste incineration plant (UIOM) in order to deduce the risk to their health.	The study is based on a retrospective analysis of existing data in the files of patients treated by the occupational medicine department	Files analysed retrospectively from 01 January 2013 to 01 September 2022 will be examined

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Major subject (≥18 years old)
Subject currently working, or having worked in the Strasbourg waste incineration plant between 01/01/2013 and 01/09/2022 within the maintenance or operating team
Subject not objecting, after being informed, to the reuse of their data for the purposes of this research
Subject in whom one or more biometrologies (blood lead level measurement, urinary cadmium level measurement, urinary 1-hydroxypyrene level measurement) were performed

Exclusion criteria:

-Subject who expressed their opposition to participating in the study

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult subject currently working, or having worked in the Strasbourg waste incineration plant between 01/01/2013 and 01/09/2022 within the maintenance or operating team

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stéphanie KLEINLOGE, MD	Contact	33 3 88 11 64 66		stephanie.kleinlogel@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Pathologie Professionnelle et Médecine du Travail - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France