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

2. oktober 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

5938

Kontakter og lokationer

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

Studiesteder

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

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

Ikke ældre end 100 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Participants diagnosed with CD, will be observed retrospectively.

Beskrivelse

Inclusion Criteria:

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

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Tilbagevirkende kraft

Kohorter og interventioner

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

Hvad måler undersøgelsen?

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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Takeda

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.

Generelle publikationer

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 (Faktiske)

26. september 2018

Primær færdiggørelse (Faktiske)

16. september 2019

Studieafslutning (Faktiske)

16. september 2019

Datoer for studieregistrering

Først indsendt

11. september 2018

Først indsendt, der opfyldte QC-kriterier

11. september 2018

Først opslået (Faktiske)

12. september 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. oktober 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. oktober 2019

Sidst verificeret

1. oktober 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IBD-5002
  • U1111-1220-0873 (Registry Identifier: WHO)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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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