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Study to Evaluate the Epidemiology and the Characteristics "Omics" in Patients Recently Diagnosed of Inflammatory Bowel Disease in Spain (IBDomics)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689257
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Brief Summary:

This is a prospective, observational, multicenter, population-based incidence cohort study which will enroll cases of inflammatory bowel disease IBD (Crohn´s disease CD, ulcerative colitis UC, or indeterminate colitis) diagnosed in adults over 18 months in Spain.

In addition, each incident case that gave his/her informed consent, will be followed up for 12 months to determine changes in phenotype or disease location, the need for immunosuppressive and biologic treatments, and the need for hospital admissions and surgery during the first year after diagnosis.

Also, samples of of blood, urine and stool will be collected during the first year after diagnosis


Condition or disease
Inflammatory Bowel Diseases

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 376 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective and Multicenter Study About the Epidemiology and the Characteristics "Omics" in Patients Recently Diagnosed of Inflammatory Bowel Disease in Spain
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020



Primary Outcome Measures :
  1. Incidence of IBD in Spain [ Time Frame: 1 year ]
    Measure the incidence of IBD in Spain


Secondary Outcome Measures :
  1. Characteristics of patients at diagnosis of inflammatory bowel disease and resources used in the first year after diagnosis [ Time Frame: 1 year ]
    Type of IBD, extension of the IBD, severity of the IBD at diagnosis. Immunosuppressive treatments, biologic drugs, surgery, and hospital

  2. Create a wide collection of samples [ Time Frame: 1 year ]
    Blood simple, urine simple, stool sample

  3. Identify the molecular and cellular pathways involved with IBD development and pathogenesis. [ Time Frame: 1 year ]
    To describe the serum proteomic profile and to characterize the density and composition of serum extracellular vesicles in newly diagnosed IBD patients, aiming to identify the molecular and cellular pathways involved with IBD development and pathogenesis.

  4. Correlate the serum proteomic profile and the density [ Time Frame: 1 year ]
    To correlate the serum proteomic profile and the density and composition of serum extracellular vesicles with IBD phenotype at diagnose and its subsequent evolution during the first year.


Biospecimen Retention:   Samples With DNA
Samples of blood, urine simple and stool sample


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients recently diagnosed of inflammatory bowel disese who have not initiated a treatment to IBD
Criteria

Inclusion Criteria:

  • Male or female ≥18 years of age diagnosed of inflammatory bowel disease
  • Diagnosis of IBD according to European Crohns and Colitis Organisation (ECCO) criteria.
  • The patient must belong to the health area of one of the participating center
  • Patients who have accepted to participate in the epidemiology study
  • < 1 month since the date of the diagnosis colonoscopy

Exclusion Criteria:

  • Patients who do not belong to the health area of the participating centers
  • Patients who do not accept to participate in the study
  • Patients who have initiated a treatment to IBD
  • Patients who received a immunomodulators to treat other disease
  • Patients with a immune-mediates systemic disease
  • Patients with a active infection or a malignancy in the baseline
  • Pregnant patients or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689257


Locations
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Spain
Hospital Universitario Mutua Terrasa
Terrassa, Barcelona, Spain, 08221
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain, 28942
Hospital Universitario Santiago de Compostela
Santiago De Compostela, Santiago De Comostela, Spain, 15706
Hospital de Galdakao
Galdakao, Vizcaya, Spain, 48960
Hospital General universitario de Alicante
Alicante, Spain, 03010
Hospital Universitario de Ciudad Real
Ciudad Real, Spain, 13005
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Hospital San Jorge
Huesca, Spain, 22004
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas De Gran Canaria, Spain, 35020
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Hospital Universitario Morale Mesenguer
Murcia, Spain, 30008
Hospital Universitario Central de Asturias
Oviedo, Spain, 33011
Hospital Universitario Son Espases
Palma De Mallorca, Spain, 07010
Hospital Universitaro Marqués de Valdecilla
Santander, Spain, 39008
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026
Hospital Clínico Univesitario de Valladolid
Valladolid, Spain, 47005
Sponsors and Collaborators
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Publications:
Burisch J, Pedersen N, Čuković-Čavka S, Brinar M, Kaimakliotis I, Duricova D, Shonová O, Vind I, Avnstrøm S, Thorsgaard N, Andersen V, Krabbe S, Dahlerup JF, Salupere R, Nielsen KR, Olsen J, Manninen P, Collin P, Tsianos EV, Katsanos KH, Ladefoged K, Lakatos L, Björnsson E, Ragnarsson G, Bailey Y, Odes S, Schwartz D, Martinato M, Lupinacci G, Milla M, De Padova A, D'Incà R, Beltrami M, Kupcinskas L, Kiudelis G, Turcan S, Tighineanu O, Mihu I, Magro F, Barros LF, Goldis A, Lazar D, Belousova E, Nikulina I, Hernandez V, Martinez-Ares D, Almer S, Zhulina Y, Halfvarson J, Arebi N, Sebastian S, Lakatos PL, Langholz E, Munkholm P; EpiCom-group. East-West gradient in the incidence of inflammatory bowel disease in Europe: the ECCO-EpiCom inception cohort. Gut. 2014 Apr;63(4):588-97. doi: 10.1136/gutjnl-2013-304636. Epub 2013 Apr 20.

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Responsible Party: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier: NCT03689257    
Other Study ID Numbers: GIS-2016-IBDomics
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa:
inflammatory bowel disease
Ulcerative colitis
Crohn´s disease
epidemiology
incidence
omics
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis