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A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD) (PREMONITION-CD)

2. oktober 2019 oppdatert av: Takeda

Characterization of a Multidimensional Model to Predict the Course of Crohn's Disease: A Pilot Study

The descriptive purpose of this study is to characterize clinical and nonclinical factors of participants with CD, participant flow and visits to other specialists in the hospitals of the healthcare network of the Autonomous Community of Madrid with implementation of electronic medical records. The clinical and nonclinical factors include: demographic and baseline clinical characteristics, lifestyle, relapses, complications, day hospital visits, surgery, presence of complications such as perianal fistulas and complex perianal fistulas. The predictive purpose of this study is to develop a statistical predictive model with the information obtained from the descriptive purpose, in the hospitals of the healthcare network of the Autonomous Community of Madrid, capable of assigning any participant diagnosed with CD a probability of reaching a prototypical clinical condition or a probability of experiencing certain clinical complications.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

This is a retrospective and non-interventional study of participants with CD. The study will collect data from electronic medical records (EMRs) of the participants in the hospitals of the healthcare network of the Autonomous Community of Madrid with implementation of EMRs and will describe the determining factors and develop a statistical model for predicting likely outcomes in participants with CD. This study will conduct an additional substudy to evaluate the performance of the system through a human assessment to be performed by the clinical experts at each participating site.

The study will have a retrospective data collection from EMRs of the participants referring to last 5 years.

The study will enroll approximately 3000 participants. All participants will be enrolled in one observational cohort.

This multi-center trial will be conducted in Spain. The overall time for data collection in the study will be approximately 5 years.

Studietype

Observasjonsmessig

Registrering (Faktiske)

5938

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Spania
      • Madrid, Spania, 28006
        • H La Princesa
    • Madrid
      • Boadilla, Madrid, Spania, 28660
        • HM hospitales
      • Fuenlabrada, Madrid, Spania, 28942
        • H. U. de Fuenlabrada
      • Majadahonda, Madrid, Spania, 28222
        • H.U. Puerta de Hierro - Majadahonda
      • Mostoles, Madrid, Spania, 28933
        • H.U. Rey Juan Carlos
      • San Sebastian de Los Reyes, Madrid, Spania, 28703
        • H.U. Infanta Sofía
      • Valdemoro, Madrid, Spania, 28342
        • H. U. Infanta Elena
      • Vallecas, Madrid, Spania, 28031
        • H Infanta Leonor y Virgen de la Torre

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 100 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Participants diagnosed with CD, will be observed retrospectively.

Beskrivelse

Inclusion Criteria:

1. Diagnosed with CD from the medical centers participating in the study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Retrospektiv

Kohorter og intervensjoner

Gruppe / Kohort
All Participants
Participants diagnosed with CD from approximately 12 to 15 investigational sites will be observed retrospectively for previous 5 years.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Number of Participants who had Relapses
Tidsramme: Approximately 5 years
Approximately 5 years
Number of Participants who had Disease Related Complications
Tidsramme: Approximately 5 years
Approximately 5 years
Number of day Hospital Visits
Tidsramme: Approximately 5 years
Approximately 5 years
Number of Participants who had Surgeries
Tidsramme: Approximately 5 years
Approximately 5 years
Number of Participants with Complications Such as Perianal Fistulas and Complex Perianal Fistulas
Tidsramme: approximately 5 years
approximately 5 years
Participant Flow
Tidsramme: Approximately 5 years
Approximately 5 years
Number of Participants who Visit to Other Specialists
Tidsramme: Approximately 5 years
Approximately 5 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prevalence of the Different Phenotypes
Tidsramme: Approximately 5 years
Development of a statistical predictive model capable of assigning any patient diagnosed with CD a probability of reaching a prototypical clinical condition or a probability of experiencing certain clinical complications.
Approximately 5 years
Number of Participants who met the Eligibility Criteria to Receive Biological Treatment for CD
Tidsramme: Approximately 5 years
Approximately 5 years
Number of Direct and Indirect Resources Used
Tidsramme: Approximately 5 years
Health care resources of participants with CD will be assessed in terms of direct and indirect resources. Direct resources will include number of hospital admissions, emergency and hospital visits, and tests performed, etc. Indirect resources related to decreased productivity of CD participants through a specific variable, the total number of work days lost due to CD during the study period.
Approximately 5 years
Number of Essential Factors on Which Physician's Predictions of Participant Outcomes are Based
Tidsramme: Approximately 5 years
Approximately 5 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Takeda

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. september 2018

Primær fullføring (Faktiske)

16. september 2019

Studiet fullført (Faktiske)

16. september 2019

Datoer for studieregistrering

Først innsendt

11. september 2018

Først innsendt som oppfylte QC-kriteriene

11. september 2018

Først lagt ut (Faktiske)

12. september 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. oktober 2019

Sist bekreftet

1. oktober 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IBD-5002
  • U1111-1220-0873 (Registeridentifikator: WHO)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

IPD-planbeskrivelse

Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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