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Progression of Damage in Ulcerative Colitis (PRODUC)

15. maj 2019 opdateret af: David Garcia Cinca
The hypothesis of the study is that in ulcerative colitis repeated flares of inflammatory activity, as well as mechanisms involved in resolution of the inflammatory response, may contribute to accumulation of damage in the colon leading to functional disturbances and symptoms that affect patient's functioning. The primary objective is to determine whether ulcerative colitis induces permanent anatomical damage, by means of magnetic resonance imaging.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Spanien
      • Barcelona, Spanien, 08036
        • Hospital Clinic De Barcelona
    • Bizkaia
      • Galdakao, Bizkaia, Spanien, 48960
        • Hospital Galdakao
    • Cordoba
      • Córdoba, Cordoba, Spanien, 14004
        • Hospital Reina Sofía
    • Madrid
      • Majadahonda, Madrid, Spanien, 28222
        • Hospital Puerta de Hierro

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

18 år til 72 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients of both sexes aged >18 years and <72 years.
  • Ulcerative colitis diagnosed according to European Crohn's and Colitis Organization guidelines .
  • Ulcerative colitis in endoscopic remission as demonstrated by a recto-sigmoidoscopy/colonoscopy (defined as: Mayo Endoscopic Score 0-1; Ulcerative Colitis Endoscopic Index of Severity : bleeding 0, vascular 0-1, erosion/ulcers 0).
  • Normal C-reactive protein according local laboratory values.
  • Informed consent for participation.
  • Understands the language of the provided patient questionnaires.

Exclusion Criteria:

  • Pregnant women (or pregnancy suspected).
  • Previous colonic surgery.
  • Patients receiving corticosteroids or antidiarrheal medications.
  • Patients with suspected or confirmed active gastrointestinal infection.
  • Patients with a diagnosis of other gastrointestinal disorders that may result in symptoms including, but not limited to, celiac disease, intolerance to disaccharides and pancreatic disorders.
  • Diabetes.
  • Thyroid disorders.
  • Liver disease.
  • Any other systemic disease that, according to the investigator's criteria, might influence the variables investigated.
  • Patients with history of colonic dysplasia.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Magnetic Resonance Imaging
A magnetic resonance imaging is perform to detect permanent anatomical damage.
Diagnostisk test: Magnetic Resonance Imaging
A magnetic resonance imaging is perform to detect permanent anatomical damage.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relationship of structural changes in colon morphology and functional changes assessed by MRI with disease duration in UC patients in clinical remission
Tidsramme: Baseline
Explorative structural changes
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient reported outcomes on IBDQ-32 questionnaire
Tidsramme: Baseline
Inflammatory bowel diseases health-related quality of life index which is a questionnaire of 32 items, score ranges from 32 to 224.
Baseline
Patient reported outcomes on EQ-5D-5L questionnaire
Tidsramme: Baseline
EQ-5D-5L questionnaire a standardized instrument for measuring generic health status, score ranges from -0.224 to 1.
Baseline
Patient reported outcomes on Work Productivity and Activity questionnaire
Tidsramme: Baseline
Work Productivity and Activity Impairment questionnaire is a well validated instrument to measure impairments in work and activities. Consists in 6 questions: question1: yes/no, questions 2 to 4: number of hours (count data), question 5: global rating scale, 0-10 (0 = health problems had no effect on my work, 10 = health problems completely prevented me from working), question 6: global rating scale, 0-10 (0 = health problems had no effect on my daily activities, 10 = health problems completely prevented me from doing my daily activities)
Baseline
Patient reported outcomes on Disability Index questionnaire
Tidsramme: Baseline
Baseline
To identify disease characteristics associated with permanent/accumulated damage disease severity with number of f the hospital admissions
Tidsramme: Baseline
Baseline
To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of corticoesteroids
Tidsramme: Baseline
Baseline
To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of immunosuppressants
Tidsramme: Baseline
Baseline
To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of biologics drugs
Tidsramme: Baseline
Baseline
To identify disease characteristics associated with permanent/accumulated damage with the disease extension at diagnosis and maximal extension of the disease at any time proctitis
Tidsramme: Baseline
Baseline
To identify disease characteristics associated with permanent/accumulated damage with the disease extension at diagnosis and maximal extension of the disease at any time left colitis
Tidsramme: Baseline
Baseline
To identify disease characteristics associated with permanent/accumulated damage with the disease extension at diagnosis and maximal extension of the disease at any time extensive colitis
Tidsramme: Baseline
Baseline
To identify disease characteristics associated with permanent/accumulated damage with the time since the disease diagnosis
Tidsramme: Baseline
Baseline
To identify disease characteristics associated with permanent/accumulated damage related to anorectal function using Cleveland Clinic Incontinence Score
Tidsramme: Baseline
Cleveland Clinic Incontinence Score is a questionnaire that reports the consistency and frequency of depositions is a 5 questions questionnaires with 7 possible answers each question.
Baseline

Samarbejdspartnere og efterforskere

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

Sponsor

David Garcia Cinca

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 (Forventet)

15. juni 2019

Primær færdiggørelse (Forventet)

31. december 2019

Studieafslutning (Forventet)

15. juni 2020

Datoer for studieregistrering

Først indsendt

10. maj 2019

Først indsendt, der opfyldte QC-kriterier

15. maj 2019

Først opslået (Faktiske)

20. maj 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. maj 2019

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HCB/2017/0842

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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Kliniske forsøg med Colitis ulcerosa

Kliniske forsøg med Magnetic Resonance Imaging

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Sponsorer og samarbejdspartnere

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Narkotikainterventioner

CROs by country

CROs in Georgia

Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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