NCT06420310

Brief Summary

The aim of this project is to study whether people exposed to pesticides have a higher risk of developing PD. We will perform an epidemiological study determining the presence of pesticides in urine and comparing signs traditionally associated with PD in early forms.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Apr 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress44%
Apr 2024Dec 2028

Study Start

First participant enrolled

April 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

4.5 years

First QC Date

May 14, 2024

Last Update Submit

May 14, 2024

Conditions

Pesticide-Induced Parkinsonism

Outcome Measures

Primary Outcomes (1)

  • Prodromal PD

    Early non motor symptoms

    over the last year

Study Arms (2)

Cases

Subjects exposed to pesticides

Other: exposure to pesticides

Controls

Subjects without any exposure to pesticides

Other: exposure to pesticides

Interventions

exposure to pesticidesOTHER

based on work exposures to pesticides

CasesControls

Eligibility Criteria

Age45 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects not diagnosed with PD living in Burgos region

You may qualify if:

  • Farmers exposed to pesticides for cases
  • No work exposure to pesticides for controls

You may not qualify if:

  • Subjects without signed consent form
  • Neurological significant conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Burgos

Burgos, 09006, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from cases and controls

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 14, 2024

First Posted

May 20, 2024

Study Start

April 1, 2024

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

December 30, 2028

Last Updated

May 20, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)