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NCT06814431Recruiting

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

Source: ClinicalTrials.gov · Last updated 24 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
3000 (estimated)
First submitted
29 Jan 2025
Start date
23 Nov 2023
Primary completion date
Dec 2026
Lead sponsor
Azienda USL Reggio Emilia - IRCCS
NCT number
NCT06814431

What you commit to

  • Study type: Observational
  • Planned participants: 3000
  • From 23 Nov 2023 to the primary completion date, Dec 2026
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Uncertain diagnosis

Who the study is looking for

  • \>18 years
  • Diagnosis of Parkinson's Disease through the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria for Parkinson's Disease.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ospedale A. Perrino
Coordinator of this site? Confirm its status
BrindisiItalyRecruiting
IRCCS Istituto Neurologico Carlo Besta
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Azienda USL IRCCS di Reggio Emilia
Coordinator of this site? Confirm its status
Reggio EmiliaItalyRecruiting
Ospedale Santa Chiara di Trento
Coordinator of this site? Confirm its status
TrentoItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.