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Shanghai Parkinson's 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.

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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. <TAB>Higher plasma levels of pro-inflammatory biomarkers predict higher PD risk.
  2. <TAB>Higher plasma uric acid is associated with a lower PD risk
  3. <TAB>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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

149

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Shanghai, Kina
        • Shanghai Cancer Institute
      • Shanghai, Kina, 200040
        • Fudan University Huashan Hospital Shanghai

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
A long-term prospective study of PD in this cohort
Tidsramme: Ongoing
Ongoing

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Gitanjali Taneja, Ph.D., National Institute of Environmental Health Sciences (NIEHS)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

14. oktober 2009

Studieafslutning

25. januar 2018

Datoer for studieregistrering

Først indsendt

20. oktober 2009

Først indsendt, der opfyldte QC-kriterier

20. oktober 2009

Først opslået (Skøn)

21. oktober 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. april 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. april 2018

Sidst verificeret

25. januar 2018

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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