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French Parkinson's Disease Cohort - NS-PARK (NS-PARK)

25 augusti 2021 uppdaterad av: Institut National de la Santé Et de la Recherche Médicale, France

Cohort of the French Clinical Research Network for Parkinson's Disease (NS-PARK Cohort)

The aim of NS-PARK cohort are to describe the natural history of Parkinson's disease (PD), and to propose patients stratification models based on PD pathophysiological mechanisms. Patients are included at all PD expert centers in France. Standardized demographic, diagnosis, motor and non-motor symptoms evaluation, and treatment information are collected, and clinical data are updated at each visit of the patient at the center. A blood sampling is perform at baseline for genetic testing and implement an associated biocollection.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

The national clinical research network for Parkinson's disease (NS-PARK/FCRIN) reassembles all expert centers in Parkinson's disease (PD) in France. Its aim is to promote clinical research in Parkinson's disease and movement disorder, to better understand the pathophysiology of PD, foster the development of new therapeutic strategies, and move towards personalized medicine. To help centers for prescreening, a national registry of PD patients followed in each centers has been implemented in 2016 to collect minimal relevant clinical information of patients followed in each center including demographic data, age at diagnosis, standardized motor and non-motor symptoms evaluation, and treatment. Data are updated at each visit of the patient in the center. De facto, this registry became a longitudinal cohort of PD patients followed in NS-PARK centers. In 2020, NS-PARK received funding to associate a biocollection to this clinical cohort.

The aim of NS-PARK cohort are to describe the natural history of PD progression in clinical routine in France, to develop new models of PD describing the different progression profiles, and to propose patients stratification based on PD pathophysiological mechanisms. The cohort will also serve as a platform to discover new PD genes and genetic modifiers of disease progression or response to treatment.

Studietyp

Observationell

Inskrivning (Förväntat)

30000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Frankrike
      • Paris, Frankrike, 75013
        • Rekrytering
        • Centre 01 Paris
        • Kontakt:
        • Huvudutredare:
          • Jean Christophe MD Corvol, Pr

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

10 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

All patients followed at one expert center for PD or associated centers in France.

Beskrivning

Inclusion Criteria:

  • Diagnosis of Parkinson's disease according to UK PD brain bak criteria
  • OR diagnosis of parkinsonian syndrome: multiple system atrophy, progressive supranuclear palsy, dementia with Lewy body, or corticobasal syndrom
  • OR Subjects at risk of PD defined as :

No symptom or diagnosis of Parkinson's disease nor parkinsonian syndrome, and relative to a patient with a diagosis of PD or parkinsonian syndrome, or carrier of a known mutation responsible for a genetic form of PD or patient with a diagnosis of idiopathic REEM sleep disorder or prodromal form of PD as defined by MDS criteria (Berg et al., 2015)

AND for all participants

  • Affiliated to social security
  • Age > 10 years

Exclusion Criteria:

  • Subject under legal protection
  • Subject who do not consent to the research
  • for the optional skin biopsy only: clinically significant coagulation abnormalities or anticoagulant treatment

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Disease progression
Tidsram: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Hoehn and Yahr score change
through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Motor and non-motor complications
Tidsram: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Occurence of motor (dyskinesia or motor fluctuations) or non-motor (dementia, dysautonomia, behavioral or psychiatric disorders, sleep disorders, falls, ...) complication
through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Modification of antiparkinsonian treatment doses
Tidsram: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Modification of antiparkinsonian treatment during follow-up will be measured as levodopa equivalent daily doses
through the end of follow-up in the cohort, at least 2 years, and average of 5 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Predictive factorsof PD progression: motor or non motor symptoms
Tidsram: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Motor or non motor symptoms as measured by MDS-UPDRS scores will be used as predictive factors for primary outcomes
through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Predictive factors of PD progression: genetic variants
Tidsram: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Genetic variants in PD genes or the Genetic PD risk score will be used as predictive factors for primary outcomes.
through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Predictive factors of PD progression: brain imaging markers
Tidsram: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Brain imaging makers (iron or neuromelanine content of the substantia nigra) will be used as predictive factors for primary outcomes
through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Clusters of patients with similar disease progression profiles
Tidsram: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Clustering analyses will be performed on disease progression markers (Hoehn and Yahr score, MDS-UPDRS scores, and doses of treatment (levodopa equivalent daily doses)) to identify homogeneous groups of patients (clusters) sharing similar disease progression profiles.
through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Clusters of patients with similar genetic and disease progression profiles
Tidsram: through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Co-clustering analysis of disease progression markers (Hoehn and Yahr score, MDS-UPDRS scores, and doses of treatment (levodopa equivalent daily doses)) and genetic markers (variants in PD genes or the Genetic PD risk score).
through the end of follow-up in the cohort, at least 2 years, and average of 5 years
Genetic mutations associated with familal forms of PD
Tidsram: through study completion, 15 years
Genetic mutations will be screened by different methods (gene panels, whole exome or whole genome) in familial forms of PD. Mutations co-segregated with PD will be considered as potentially associated with the disease.
through study completion, 15 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Utredare

  • Huvudutredare: Jean Christophe MD CORVOL, PU-PH, UMRS 1127

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 juni 2021

Primärt slutförande (Förväntat)

15 augusti 2023

Avslutad studie (Förväntat)

31 december 2023

Studieregistreringsdatum

Först inskickad

19 april 2021

Först inskickad som uppfyllde QC-kriterierna

11 maj 2021

Första postat (Faktisk)

17 maj 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 augusti 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 augusti 2021

Senast verifierad

1 augusti 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • C16-56
  • 2019-A01929-48 (Registeridentifierare: RCB ID)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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