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Shanghai Parkinson's Study


N/A
40 Years
N/A
Not Enrolling
Female
Parkinson's Disease

Thank you

Trial Information

Shanghai Parkinson's Study


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

1. Higher plasma levels of pro-inflammatory biomarkers predict higher PD risk.

2. Higher plasma uric acid is associated with a lower PD risk

3. Environmental tobacco smoke (ETS) is associated with lower PD risk

1. Self-reported ETS exposure is associated with a lower PD risk

2. 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.

Inclusion Criteria


- Inclusion and exclusion criteria:

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.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Honglei Chen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Environmental Health Sciences (NIEHS)

Authority:

United States: Federal Government

Study ID:

999910001

NCT ID:

NCT00999388

Start Date:

October 2009

Completion Date:

Related Keywords:

  • Parkinson's Disease
  • Lifestyle
  • Environment
  • Neurodegenerative Diseases
  • Elderly
  • Public Health
  • PD
  • Parkinson Disease
  • Parkinson Disease

Name

Location

Vanderbilt University Nashville, Tennessee  37232-6305
NIEHS, Research Triangle Park Research Triangle Park, North Carolina  27709
National Cancer Institute (NCI), 6120 Executive Blvd Rockville, Maryland  20892-7240
Social & Scientific Systems, 1009 Slater Road, Suite 120 Durham, North Carolina  27703