Idiopathic Parkinson's Disease (PD)
Conditions
Keywords
Parkinson's Disease, Neoplasms, GBA1, Genetic Parkinson's Disease
Brief summary
This multicenter retrospective observational study investigates the incidence of malignant neoplasms in Parkinson's disease (PD) patients carrying heterozygous pathogenic variants in the GBA1 gene. The study compares these patients to individuals with idiopathic PD and to the general population within a large national cohort. The rationale for the study lies in the growing evidence indicating an increased risk of malignant neoplasms in patients affected by Gaucher disease. The primary objective is to assess whether PD patients with GBA1 mutations have a higher incidence of malignant neoplasms compared to the general population. Secondary objectives include comparing the incidence of malignant neoplasms between GBA1-PD and idiopathic PD patients, as well as between idiopathic PD patients and the general population. Additionally, the study aims to characterize oncological conditions by sex, age, center, and tumor site, with specific attention to distinguishing hematologic tumors from solid tumors. By identifying potential associations between GBA1 mutations and malignancies in PD, the findings could guide more comprehensive patient management, including screening for malignant neoplasms alongside Parkinson's disease care.
Detailed description
The study will involve a network composed by different Italian Movement Disorders Centres and the corresponding local cancer registries, responsible for the active collection of cancer cases. Data will be collected from approximately 3000 consecutive Parkinson's disease (PD) patients, including about 500 patients carrying GBA1 mutations and 2500 idiopathic PD. Data about the presence of malignancies will be extracted from the Local Cancer Registries for each patient.
Interventions
None listed
Sponsors
Azienda USL Reggio Emilia - IRCCS
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>18 years * Diagnosis of Parkinson's Disease through the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria for Parkinson's Disease.
Exclusion criteria
* Uncertain diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Increased Incidence of Malignant Neoplasms in Parkinson's Disease Patients with GBA1 Mutation Compared to the General Population | From birth to a maximum of 36 months after enrollment | The incidence of malignant neoplasms in Parkinson's disease (PD) patients carrying the GBA1 mutation (GBA1-PD) will be calculated and compared to that of the general population to assess any potential increase in risk. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Increased Incidence of Malignant Neoplasms in Parkinson's Disease Patients with GBA1 Mutation Compared to Non-Genetic Parkinson's Disease Patients | From birth to a maximum of 36 months after enrollment | The incidence of malignant neoplasms in Parkinson's disease (PD) patients carrying the GBA1 mutation (GBA1-PD) will be compared to that of idiopathic PD patients using a Chi-Square test to evaluate statistical significance |
| Evaluation of Increased Incidence of Malignant Neoplasms in Idiopathic Parkinson's Disease Patients Compared to the General Population | From birth to a maximum of 36 months after enrollment | The incidence of neoplasms in patients with idiopathic Parkinson's disease (PD) will be compared to that of the general population. |
| Description of Oncological Condition Incidence by Sex, Age, Center, and Tumor Site, with Specific Focus on Hematologic Versus Solid Tumors | From birth to a maximum of 36 months after enrollment | Logistic regression analysis will be conducted to evaluate the association between neoplasms and PD subgroups (GBA1 and idiopathic PD), accounting for clinical and demographic covariates. |
Countries
Italy
Contacts
CONTACTGiulia Di Rauso, MD
Outcome results
None listed