Parkinson's DiseaseNCT04926909
Study on Serum Cystatin C and PET-DAT in Patients With Parkinson's Disease
An observational study of Parkinson's Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To investigate the relationship between serum cystatin C and dopamine receptor(DAT) loss in patients with parkinson's disease(PD) Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Parkinson's Disease
- How many people
- 121 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 1 Aug 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pearson correlation analysis is planned, and the sample size is calculated with PASS 15.0 software. 121 participants required after sample size calculation. The calculation parameters are as follows: Power = 0.90, α=0.05, ρ0 = 0.0, and ρ1 = 0.3.
Who may be able to join
- Patients aged between 20 and 80 years and whose laboratory results included the levels of serum Cystatin C within a month from the PET-DAT were recruited.
Who cannot join
- To make the study cohort more homogeneous, PD patients with either a long-standing duration (≥5 years) or advanced Hoehn and Yahr (H\&Y) staging (≥3) were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
BaoRong Zhang, MD, 13958167260, brzhang@zju.edu.cn
About this study
Official title: The Relationship Between Serum Cystatin C and PET-DAT Study in Patients With Parkinson's Disease
To investigate the relationship between serum cystatin C and dopamine receptor(DAT) loss in patients with parkinson's disease(PD)
Read the detailed description
Number of people suffered from Parkinson disease (PD) is increasing every year. PET imaging of dopamine transport receptors（DAT） serves as the gold standard for the diagnosis and monitoring of PD development. However, due to high costs and radiation reasons, it is not suitable for long-term follow-up. Serum cystatin C can be easily obtained and cheap as an indicator. In recent years, studies have gradually found that it is related to the progression of H\&Y staging of Parkinson's disease. To this extent, we want to further explore whether it can reflect the loss of DAT in the brain. Explore whether it can partially replace the role of DAT imaging for future clinical evaluation.
- Conditions
- Parkinson's Disease
- Keywords
- Cystatin C, PET-DAT
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Cystatin C assesses the loss of dopaminergic neurons
Explore whether Cystatin C can respond to the loss of dopaminergic neurons
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start1 Jul 2020
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 121 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926909
- Sponsor's protocol ID
- 2020-079
- Status last verified
- Mar 2021
- First submitted
- 9 Jun 2021
- Last updated
- 15 Jun 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Serum Cystatin C and PET-DAT Study in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04926909
- Acronym / sponsor ID
- 2020-079
- Conditions
- Parkinson's Disease
- Keywords
- Cystatin C, PET-DAT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 15 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the relationship between serum cystatin C and dopamine receptor(DAT) loss in patients with parkinson's disease(PD)
Detailed description
Number of people suffered from Parkinson disease (PD) is increasing every year. PET imaging of dopamine transport receptors（DAT） serves as the gold standard for the diagnosis and monitoring of PD development. However, due to high costs and radiation reasons, it is not suitable for long-term follow-up. Serum cystatin C can be easily obtained and cheap as an indicator. In recent years, studies have gradually found that it is related to the progression of H\&Y staging of Parkinson's disease. To this extent, we want to further explore whether it can reflect the loss of DAT in the brain. Explore whether it can partially replace the role of DAT imaging for future clinical evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pearson correlation analysis is planned, and the sample size is calculated with PASS 15.0 software. 121 participants required after sample size calculation. The calculation parameters are as follows: Power = 0.90, α=0.05, ρ0 = 0.0, and ρ1 = 0.3.
Key inclusion criteria (1 listed)
- Patients aged between 20 and 80 years and whose laboratory results included the levels of serum Cystatin C within a month from the PET-DAT were recruited.
Key exclusion criteria (1 listed)
- To make the study cohort more homogeneous, PD patients with either a long-standing duration (≥5 years) or advanced Hoehn and Yahr (H\&Y) staging (≥3) were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cystatin C assesses the loss of dopaminergic neurons
Time frame: through study completion, an average of 1 year
Explore whether Cystatin C can respond to the loss of dopaminergic neurons
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BaoRong Zhang, MD (13958167260, brzhang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cystatin C assesses the loss of dopaminergic neurons (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.