Actively Recruiting

Age: 18Years +
All Genders
ID06814431

Study on the Incidence of Malignant Neoplasms in Patients with Parkinson's Disease and Heterozygous Mutation of the GBA Gene

Led by Azienda USL Reggio Emilia - IRCCS · Updated on 2025-02-11

3000

Participants Needed

4

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates the occurrence of malignant tumors in people with Parkinson's disease (PD) who carry a specific gene change called a heterozygous pathogenic variant in the GBA1 gene. The study compares these individuals with those who have idiopathic PD (PD without these gene changes) and with the general population. The study aims to understand if there is a higher risk of cancer in PD patients with the GBA1 mutation and to explore patterns by sex, age, and tumor type. The study collects data from about 3000 PD patients across multiple movement disorder centers in Italy, including around 500 with the GBA1 mutation and 2500 with idiopathic PD. Information about cancer cases for these patients is gathered from local cancer registries. Participants are grouped into those with PD and the GBA1 mutation and those with idiopathic PD, with diagnoses based on established criteria. Participants' medical histories related to cancer are reviewed using cancer registry data. The main outcome is to compare the rate of malignant tumors in PD patients with GBA1 mutations to the general population over a period from birth up to 36 months after joining the study. Secondary analyses include comparisons between the different PD groups and detailed descriptions of cancer types by patient characteristics. The study helps understand cancer risks in PD and may guide future patient care.

CONDITIONS

Brief Title

Study on the Incidence of Malignant Neoplasms in Patients with Parkinson's Disease and Heterozygous Mutation of the GBA Gene

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Diagnosis of Parkinson's Disease based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria
Not Eligible

You will not qualify if you...

  • Uncertain diagnosis of Parkinson's Disease

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Up to 36 months after enrollment

Participants are observed for the occurrence of malignant neoplasms through data collected from local cancer registries and movement disorder centers.

Data collection from registries without additional visits

Trial Site Locations

Total: 4 locations

1

Ospedale A. Perrino

Brindisi, Italy

Actively Recruiting

2

IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

Actively Recruiting

3

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Italy, 42123

Actively Recruiting

4

Ospedale Santa Chiara di Trento

Trento, Italy

Actively Recruiting

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Research Team

F

Franco Valzania, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial