## Protocol Section
### Identification Module
**NCT ID:** NCT06420310

**Acronym:** Pest-PD

**Brief Title:** Pesticides and Parkinson´s Disease

**Official Title:** Prevalence of Preclinical and Prodromal Parkinson´s Disease in Subjects Exposed to Pesticides

#### Organization Study ID Info
**ID:** GRS 2682/A1/2023
#### Organization
**Class:** OTHER
**Full Name:** Hospital Universitario de Burgos
### Status Module
#### Completion Date
**Date:** 2028-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2028-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospital Universitario de Burgos

#### Responsible Party

**Investigator Affiliation:** Hospital Universitario de Burgos

**Investigator Full Name:** Esther Cubo

**Investigator Title:** MD, PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed Description:** Within different risk factors, pesticide exposure increases the risk of developing Parkinson's disease (PD) through epigenetic mechanisms by modifying the expression of genes related to PD and secondary mitochondrial dysfunction.We will conduct a cross-sectional prevalence study with cases (exposed to pesticides) and controls (not exposed to pesticides), randomly selecting 130 individuals in each group. Pesticide exposure will be determined through questionnaires.We will study the prevalence of preclinical and prodromal PD based on pesticide exposure, stratified by age and gender in the exposed, and non-exposed groups. Preclinical and prodromal PD will be assessed using: biological biomarkers and prodromal PD signs. Multivariate analyses will be employed to determine the risk of presenting early PD, adjusting for different clinical covariates. The results of this study will allow us to understand the early mechanisms associated with neurodegeneration and pesticides exposure.

### Conditions Module

**Conditions:**

- Pesticide-Induced Parkinsonism

### Design Module

#### Bio Spec

**Description:** Blood samples from cases and controls

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 260

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 3 Years

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects exposed to pesticides

**Intervention Names:**

- Other: exposure to pesticides

**Label:** Cases

#### Arm Group 2

**Description:** Subjects without any exposure to pesticides

**Intervention Names:**

- Other: exposure to pesticides

**Label:** Controls

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cases

- Controls

**Description:** based on work exposures to pesticides

**Name:** exposure to pesticides

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Early non motor symptoms

**Measure:** Prodromal PD

**Time Frame:** over the last year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* Subjects without signed consent form
* Neurological significant conditions

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 45 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

**Study Population:** Subjects not diagnosed with PD living in Burgos region

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Burgos

**Contacts:**

***Contact 1:***

- **Email:** mcubo@saludcastillayleon.es

- **Name:** Esther Cubo, MD

- **Phone:** +34947256533

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Universitario de Burgos

**Status:** RECRUITING

**Zip:** 09006

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001480

- Term: Basal Ganglia Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009069

- Term: Movement Disorders

- ID: D000080874

- Term: Synucleinopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M13213

- Name: Parkinson Disease

- Relevance: HIGH

- As Found: Parkinson's Disease

- ID: M22494

- Name: Parkinsonian Disorders

- Relevance: HIGH

- As Found: Parkinsonism

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M4774

- Name: Basal Ganglia Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12029

- Name: Movement Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M2217

- Name: Synucleinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010300

- Term: Parkinson Disease

- ID: D000020734

- Term: Parkinsonian Disorders

### Misc Info Module

- Version Holder: 2024-05-31
