Determine cancer risk in Parkinson
- Trial ID
- NCT06814431
- Official Title
- Study on the Incidence of Malignant Neoplasms in Patients with Parkinson's Disease and Heterozygous Mutation of the GBA Gene
- Goal
- Determine cancer risk in Parkinson
- Status
- RECRUITING
- Sponsor
- Azienda USL Reggio Emilia - IRCCS
- Study Type
- OBSERVATIONAL
- Enrollment
- 3000 participants
- Conditions
- Idiopathic Parkinson's Disease (PD)
Summary For Families
Researchers want to know whether people with Parkinson's who carry a single (heterozygous) mutation in the GBA gene have higher rates of malignant cancers than other people with Parkinson's. They will follow about 3,000 adults with Parkinson's, determine who has a heterozygous GBA mutation, and track new cancer diagnoses through medical records and registries; since the work is observational, no experimental treatment is given. GBA makes the enzyme glucocerebrosidase, which helps lysosomes clear cellular waste, and reduced enzyme activity can alter cell biology in ways that might influence cancer risk, so the study is looking for those patterns. Adults 18 and older with Parkinson's confirmed by the UK Brain Bank criteria are eligible, people with an uncertain diagnosis are excluded.
Locations
- Ospedale A. Perrino, Brindisi, Italy
- IRCCS Istituto Neurologico Carlo Besta, Milan, Italy
- Azienda USL IRCCS di Reggio Emilia, Reggio Emilia, Italy
- Ospedale Santa Chiara di Trento, Trento, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. Researchers want to know whether people with Parkinson's who carry a single (heterozygous) mutation in the GBA gene have higher rates of malignant cancers than other people with Parkinson's. They will follow about 3,000 adults with Parkinson's, determine who has a heterozygous GBA mutation, and track new cancer diagnoses through medical records and registries; since the work is observational, no experimental treatment is given. GBA makes the enzyme glucocerebrosidase, which helps lysosomes clear cellular waste, and reduced enzyme activity can alter cell biology in ways that might influence cancer risk, so the study is looking for those patterns. Adults 18 and older with Parkinson's confirmed by the UK Brain Bank criteria are eligible, people with an uncertain diagnosis are excluded.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 4 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.