Parkinson's Trial NCT06814431
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 2 years.
- 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.
- 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.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.