NCT05256212

Brief Summary

The aim of the current trial is to assess the exposure of firefighters (FF) to environmental pollutants emitted from fires, to explore the association of exposure with their health status and to compare these data with those of non-FF participants

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

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

August 15, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 10, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

3.4 years

First QC Date

January 10, 2022

Last Update Submit

July 30, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • PBDEs levels, measured in serum by GC-MS

    to test for PBDE levels in blood

    Day 1- day of recruitment

  • BTEX levels, measured in urine by LC-MS/MS

    to test for BTEX levels in blood

    Day 1- day of recruitment

  • Heavy metals (Pb, Hg, Cd) levels, measured in urine by ICP-MS

    to test for Heavy metals levels

    Day 1- day of recruitment

Secondary Outcomes (3)

  • Liver enzymes levels (x2 of Upper Limit of Normal), measured in serum

    Day 1- day of recruitment

  • renal function (eGFR<60), by creatinine level measured in serum

    Day 1- day of recruitment

  • Thyroid function (TSH or FT4 out of lab reference values) measured in serum

    Day 1- day of recruitment

Study Arms (1)

firefighters

firefighters in active service

Other: exposure to environmental contaminants

Interventions

exposure to environmental contaminantsOTHER

to measure levels of contaminants in different matrixes

firefighters

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Firefighters

You may qualify if:

  • \* active firefighters

You may not qualify if:

  • \* Women
  • firefighters with known liver, renal or thyroid problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Biospecimen

Retention: NONE RETAINED

urine, serum, full blood

Study Officials

  • Matityahu Berkovitch, Prof

    Shamir MC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research- Clinical Pharmacology and Toxicology

Study Record Dates

First Submitted

January 10, 2022

First Posted

February 25, 2022

Study Start

August 15, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2023

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

IPD to be shared as needed for QA purposes

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
from January 22 till December 2022
Access Criteria
for QA analysis of reviewers

Locations

IL(1)