NCT06814431 Study on the Incidence of Malignant Neoplasms in Patients With Parkinson's Disease and Heterozygous Mutation of the GBA Gene
| NCT ID | NCT06814431 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda USL Reggio Emilia - IRCCS |
| Condition | Idiopathic Parkinson's Disease (PD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2023-11-23 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2023-11-23 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06814431 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Idiopathic Parkinson's Disease (PD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06814431 currently recruiting?
Yes, NCT06814431 is actively recruiting participants. Contact the research team at giulia.dirauso@ausl.re.it for enrollment information.
Where is the NCT06814431 trial being conducted?
This trial is being conducted at Brindisi, Italy, Milan, Italy, Reggio Emilia, Italy, Trento, Italy.
Who is sponsoring the NCT06814431 clinical trial?
NCT06814431 is sponsored by Azienda USL Reggio Emilia - IRCCS. The trial plans to enroll 3,000 participants.
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