Parkinson's DiseaseNCT00999388
Shanghai Parkinson's Study
An observational study of Parkinson's Disease, run by National Institute of Environmental Health Sciences (NIEHS) at 2 sites in China.
Trial summary
Background: Parkinson disease (PD) is the second most prevalent neurodegenerative disease, affecting more than 1 percent of the elderly population in the United States and other Western countries. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- How many people
- 149 participants
- Where
- 2 sitesChina
- Study dates
- 14 Oct 2009to 25 Jan 2018
- 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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- This study will be conducted within the infrastructure of the Shanghai Women s Health Study. At this stage, all self-reported PD cases through the 4th follow-up will be invited. As the 4th follow-up is ongoing, we will start with cases identified from the first three follow-ups and add new cases as they are identified. Through the 3rd follow-up, a total of 220 PD patients have self-identified and 141 are incident. Assuming 200 cases are still alive at the time of the proposed study and another 80 are self-identified during the 4th follow-up, we will have approximately 280 self-reported PD patients that are eligible for the clinical confirmation at current stage. Cases identified from future SWHS follow-ups will be eligible for future SPS work.
- Analyses on biomarkers and genes will be conducted in a case-control manner. Overall, two controls will be selected for each case, individually matched on year of birth (+/-1), and maybe some other factors such as survival status, baseline menopausal status, fasting status, season of specimen collection, and time of the day of specimen collection. These controls have provided exposure data and/or biospecimen at baseline. Therefore at current stage no active field data collection will be carried out for controls.
- As at the current stage, the expected number of Parkinson cases is small, therefore we do not plan to pre-exclude any participants from this study.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Fudan University Huashan Hospital Shanghai
Shanghai, 200040
Shanghai Cancer Institute
Shanghai
About this study
Background:
- Parkinson disease (PD) is the second most prevalent neurodegenerative disease, affecting more than 1 percent of the elderly population in the United States and other Western countries. Although effective treatments can alleviate symptoms in early PD, no cure or treatment slowing disease progression has been identified, and patients will eventually develop severe physical and mental disabilities and often die of complications. More research is needed on the causes of and appropriate preventive strategies for PD.
- The Shanghai Women s Health Study (SWHS) was established 10 years ago by investigators from the Vanderbilt University, the Shanghai Cancer Institute (SCI) and the National Cancer Institute (NCI) of the US. Their primary aim was to examine several unique dietary hypotheses on cancer among Chinese women. Researchers from the National Institute of Environmental Health Sciences and SWHS investigators are now interested in studying PD patients from SWHS to evaluate biological and environmental factors that may have put them at risk for PD.
Read more
Objectives:
- To initiate a long-term prospective study on PD in Chinese women from the Shanghai Women s Health Study.
- To examine a set of biological and environmental factors that may raise or lower risk of developing PD.
Eligibility:
- All participants of the SWHS cohort are eligible.
Design:
- Researchers will contact self-reported PD cases from the SWHS, confirm (or reject) the self-report, and invite them to a clinical examination at a coordinating hospital in Shanghai.
- Cases that confirm the self-report will be invited to visit the coordinating hospital for clinical examinations, including a PD clinical workup, blood and urine collections, a cognitive assessment and relevant neuropsychological testing, and an interview on additional risk factor exposures that are not available from baseline surveys.
- For those who could not participate in the clinical examination, researchers will ask for a few details about the diagnosis and treatment history and ask for permission to obtain medical records relevant to PD diagnosis from government or hospital agencies.
- For self-reported PD cases who are now deceased, researchers will follow a similar procedure by asking for consent and help from the next-of-kin.
Read the detailed description
We propose to clinically examine self-reported Parkinson s disease (PD) patients from the well established Shanghai Women s Health Study (SWHS) and thus initiate a long-term PD research in this unique Chinese women cohort. The SWHS cohort was established in late 1990s by Dr. Wei Zheng from Vanderbilt University in collaboration with investigators from the Shanghai Cancer Institute (SCI) and the National Cancer Institute (NCI) of the US. Their primary aim was to examine several unique dietary hypotheses on cancer among Chinese women. From 1996 to 2000, the SWHS successfully recruited 74,942 Chinese women, aged 40 to 70, from selected communities in a single district in Shanghai with an overall consent rate of 92%. All participants completed a comprehensive baseline survey, 88% donated urine, 76% donated blood, and an additional 12% donated buccal cells.1 Follow-up surveys have since been conducted biennially with consistent participation rates of 95% or higher. Through the 3rd follow-up, the cohort has documented 220 self-reported PD cases and we expect to identify another 80 self-reports during the ongoing 4th follow-up survey (2007-2010). We hereby propose to clinically examine self-reported PD patients to achieve the following two major aims.
Aim #1: To initiate a long-term prospective study on PD in this unique Chinese women cohort
Aim #2: To examine the following specific hypotheses among women
- <TAB>Higher plasma levels of pro-inflammatory biomarkers predict higher PD risk.
- <TAB>Higher plasma uric acid is associated with a lower PD risk
- <TAB>Environmental tobacco smoke (ETS) is associated with lower PD risk
- Self-reported ETS exposure is associated with a lower PD risk
- Higher urine level of cotinine is associated with a lower PD risk
We hereby propose a prospective study on PD in a unique women-only cohort. The infrastructure and the many desirable characteristics of this cohort offer us a rare opportunity for PD research in women, particularly on biomarkers. We expect to establish it as a long-term and excellent resource for PD research in women in the future. In the short term, we plan to examine several promising PD hypotheses that have not been adequately evaluated among women. These findings will apply directly to Chinese women and may also have implications for women in the West. PD etiological research is under-represented in women. Therefore, research in the SPS may not only corroborate findings on women in the west, but also lead to the identification of novel risk factors that could be generalizable to Western women.
- Conditions
- Parkinson's Disease
- Keywords
- Lifestyle, Environment, Neurodegenerative Diseases, Elderly, Public Health, PD, Parkinson Disease
- Medical subject headings
- Parkinson Disease, Neurodegenerative Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
A long-term prospective study of PD in this cohort
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study start14 Oct 2009
- Study completion25 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gitanjali Taneja, Ph.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999388
- Sponsor's protocol ID
- 999910001
- Other IDs
- 10-E-N001
- Status last verified
- 25 Jan 2018
- First submitted
- 20 Oct 2009
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Gasser T. Genetics of Parkinson's disease. Curr Opin Neurol. 2005 Aug;18(4):363-9. doi: 10.1097/01.wco.0000170951.08924.3d.
PubMed 16003110Tanner CM, Ottman R, Goldman SM, Ellenberg J, Chan P, Mayeux R, Langston JW. Parkinson disease in twins: an etiologic study. JAMA. 1999 Jan 27;281(4):341-6. doi: 10.1001/jama.281.4.341.
PubMed 9929087Hernan MA, Takkouche B, Caamano-Isorna F, Gestal-Otero JJ. A meta-analysis of coffee drinking, cigarette smoking, and the risk of Parkinson's disease. Ann Neurol. 2002 Sep;52(3):276-84. doi: 10.1002/ana.10277.
PubMed 12205639
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Parkinson's Study
- ClinicalTrials.gov ID
- NCT00999388
- Acronym / sponsor ID
- 999910001
- Conditions
- Parkinson's Disease
- Keywords
- Lifestyle, Environment, Neurodegenerative Diseases, Elderly, Public Health, PD, Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 14 Oct 2009
- Study completion
- 25 Jan 2018
- First posted
- 21 Oct 2009 (estimated)
- 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.
Background:
- Parkinson disease (PD) is the second most prevalent neurodegenerative disease, affecting more than 1 percent of the elderly population in the United States and other Western countries. Although effective treatments can alleviate symptoms in early PD, no cure or treatment slowing disease progression has been identified, and patients will eventually develop severe physical and mental disabilities and often die of complications. More research is needed on the causes of and appropriate preventive strategies for PD.
- The Shanghai Women s Health Study (SWHS) was established 10 years ago by investigators from the Vanderbilt University, the Shanghai Cancer Institute (SCI) and the National Cancer Institute (NCI) of the US. Their primary aim was to examine several unique dietary hypotheses on cancer among Chinese women. Researchers from the National Institute of Environmental Health Sciences and SWHS investigators are now interested in studying PD patients from SWHS to evaluate biological and environmental factors that may have put them at risk for PD.
Objectives:
- To initiate a long-term prospective study on PD in Chinese women from the Shanghai Women s Health Study.
- To examine a set of biological and environmental factors that may raise or lower risk of developing PD.
Eligibility:
- All participants of the SWHS cohort are eligible.
Design:
- Researchers will contact self-reported PD cases from the SWHS, confirm (or reject) the self-report, and invite them to a clinical examination at a coordinating hospital in Shanghai.
- Cases that confirm the self-report will be invited to visit the coordinating hospital for clinical examinations, including a PD clinical workup, blood and urine collections, a cognitive assessment and relevant neuropsychological testing, and an interview on additional risk factor exposures that are not available from baseline surveys.
- For those who could not participate in the clinical examination, researchers will ask for a few details about the diagnosis and treatment history and ask for permission to obtain medical records relevant to PD diagnosis from government or hospital agencies.
- For self-reported PD cases who are now deceased, researchers will follow a similar procedure by asking for consent and help from the next-of-kin.
Detailed description
We propose to clinically examine self-reported Parkinson s disease (PD) patients from the well established Shanghai Women s Health Study (SWHS) and thus initiate a long-term PD research in this unique Chinese women cohort. The SWHS cohort was established in late 1990s by Dr. Wei Zheng from Vanderbilt University in collaboration with investigators from the Shanghai Cancer Institute (SCI) and the National Cancer Institute (NCI) of the US. Their primary aim was to examine several unique dietary hypotheses on cancer among Chinese women. From 1996 to 2000, the SWHS successfully recruited 74,942 Chinese women, aged 40 to 70, from selected communities in a single district in Shanghai with an overall consent rate of 92%. All participants completed a comprehensive baseline survey, 88% donated urine, 76% donated blood, and an additional 12% donated buccal cells.1 Follow-up surveys have since been conducted biennially with consistent participation rates of 95% or higher. Through the 3rd follow-up, the cohort has documented 220 self-reported PD cases and we expect to identify another 80 self-reports during the ongoing 4th follow-up survey (2007-2010). We hereby propose to clinically examine self-reported PD patients to achieve the following two major aims.
Aim #1: To initiate a long-term prospective study on PD in this unique Chinese women cohort
Aim #2: To examine the following specific hypotheses among women
- <TAB>Higher plasma levels of pro-inflammatory biomarkers predict higher PD risk.
- <TAB>Higher plasma uric acid is associated with a lower PD risk
- <TAB>Environmental tobacco smoke (ETS) is associated with lower PD risk
- Self-reported ETS exposure is associated with a lower PD risk
- Higher urine level of cotinine is associated with a lower PD risk
We hereby propose a prospective study on PD in a unique women-only cohort. The infrastructure and the many desirable characteristics of this cohort offer us a rare opportunity for PD research in women, particularly on biomarkers. We expect to establish it as a long-term and excellent resource for PD research in women in the future. In the short term, we plan to examine several promising PD hypotheses that have not been adequately evaluated among women. These findings will apply directly to Chinese women and may also have implications for women in the West. PD etiological research is under-represented in women. Therefore, research in the SPS may not only corroborate findings on women in the west, but also lead to the identification of novel risk factors that could be generalizable to Western women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- This study will be conducted within the infrastructure of the Shanghai Women s Health Study. At this stage, all self-reported PD cases through the 4th follow-up will be invited. As the 4th follow-up is ongoing, we will start with cases identified from the first three follow-ups and add new cases as they are identified. Through the 3rd follow-up, a total of 220 PD patients have self-identified and 141 are incident. Assuming 200 cases are still alive at the time of the proposed study and another 80 are self-identified during the 4th follow-up, we will have approximately 280 self-reported PD patients that are eligible for the clinical confirmation at current stage. Cases identified from future SWHS follow-ups will be eligible for future SPS work.
- Analyses on biomarkers and genes will be conducted in a case-control manner. Overall, two controls will be selected for each case, individually matched on year of birth (+/-1), and maybe some other factors such as survival status, baseline menopausal status, fasting status, season of specimen collection, and time of the day of specimen collection. These controls have provided exposure data and/or biospecimen at baseline. Therefore at current stage no active field data collection will be carried out for controls.
- As at the current stage, the expected number of Parkinson cases is small, therefore we do not plan to pre-exclude any participants from this study.
Key exclusion criteria (0 listed)
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
A long-term prospective study of PD in this cohort
Time frame: Ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 16003110Gasser T. Genetics of Parkinson's disease. Curr Opin Neurol. 2005 Aug;18(4):363-9. doi: 10.1097/01.wco.0000170951.08924.3d.
- Background: PubMed 9929087Tanner CM, Ottman R, Goldman SM, Ellenberg J, Chan P, Mayeux R, Langston JW. Parkinson disease in twins: an etiologic study. JAMA. 1999 Jan 27;281(4):341-6. doi: 10.1001/jama.281.4.341.
- Background: PubMed 12205639Hernan MA, Takkouche B, Caamano-Isorna F, Gestal-Otero JJ. A meta-analysis of coffee drinking, cigarette smoking, and the risk of Parkinson's disease. Ann Neurol. 2002 Sep;52(3):276-84. doi: 10.1002/ana.10277.
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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.
Gitanjali Taneja, Ph.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
2 sites 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 National Institute of Environmental Health Sciences (NIEHS) at 2 sites 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 3 inclusion and 0 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: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A long-term prospective study of PD in this cohort (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00999388, which also lists 3 linked publications.
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 5 Apr 2018.