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An Epidemiological Study of the Incidence of Inflammatory Bowel Disease in Spain (INCIDENCIA)

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ClinicalTrials.gov Identifier: NCT02686892
Recruitment Status : Recruiting
First Posted : February 22, 2016
Last Update Posted : August 14, 2017
Sponsor:
Collaborator:
Grupo Español de trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)
Information provided by (Responsible Party):
Javier P. Gisbert, 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 IBD (CD, UC, or indeterminate colitis) diagnosed in adults over 1 year 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.


Condition or disease
Inflammatory Bowel Disease

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: An Epidemiological Study of the Incidence of Inflammatory Bowel Disease in Spain
Study Start Date : January 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Group/Cohort
Group
Spanish territory population of 46,439,864 inhabitants
Cohort
Incident cases diagnosed with IBD over 12 months in the Spanish territory



Primary Outcome Measures :
  1. Number of participants with the incidence of inflammatory bowel disease in Spain [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Number of patients with incidece of inflammatory bowel disease in diferent regions of the spanish territory [ Time Frame: 1 year ]
  2. Characteristics of patients at diagnosis of inflammatory bowel disease [ Time Frame: 1 year ]
    Type of IBD, extension of the IBD, severity of the IBD at diagnosis

  3. Resourses used in the first year after diagnosis. [ Time Frame: 1 year ]
    immunosuppressive treatments, biologic drugs, surgery, and hospital admissions

  4. Delay from onset of symptoms to diagnosis of the disease [ Time Frame: 1 year ]
    start date of symptoms, date of first visit to the family doctor, date of first visit to specialist, date of diagnosis.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This is a descriptive observational study in which the whole Spanish population will be considered and which will include all incident cases of inflammatory bowel disease occurring in a year.
Criteria

Inclusion Criteria:

  • Patients over 18 years of age diagnosed with IBD.
  • 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

Exclusion Criteria:

  • Patients who do not accept to participate in the study

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): NCT02686892


Contacts
Contact: Javier Perez Gisbert, MD PhD +34913093911 javier.p.gisbert@gmail.com
Contact: Eva Rodriguez +915202425 secretariacientificageteccu@gmail.com

Locations
Spain
Hospital Universitario Reina Sofía Not yet recruiting
Córdoba, Andalucía, Spain
Contact: Valle García, PhD         
Hospital Clínico Universitario 'Lozano Blesa' Not yet recruiting
Zaragoza, Aragón, Spain
Contact: Fernando Gomollón, PhD         
Hospital Son Llatzer Not yet recruiting
Palma de Mallorca, Baleares, Spain
Contact: Daniel Ginard, PhD         
Hospital Universitari Mutua Terrassa Not yet recruiting
Terrassa, Barcelona, Spain
Contact: Maria Esteve, PhD         
Hospital Universitario de Gran Canaria Dr Negrín Not yet recruiting
Las Palmas, Canarias, Spain
Contact: Daniel Ceballos, PhD         
Hospital Universitario Marques de Valdecilla Not yet recruiting
Santander, Cantabria, Spain
Contact: Montserrat Rivero, PhD         
Hospital General de Ciudad Real Not yet recruiting
Ciudad Real, Castilla La Mancha, Spain
Contact: Rufo Lorente, PhD         
Hospital Universitario de Burgos Not yet recruiting
Burgos, Castilla y León, Spain
Contact: Beatriz Sicilia, PhD         
Hospital San Pedro de Alcántara Not yet recruiting
Cáceres, Extremadura, Spain
Contact: Pilar Robledo, PhD         
Hospital Clínico Universitario de Santiago de Compostela Not yet recruiting
Santiago de Compostela, Galicia, Spain
Contact: Manuel Barreiro, PhD         
Hospital San Pedro Not yet recruiting
Logroño, La Rioja, Spain
Contact: Hipólito Fernandez Rosaenz, PhD         
Complejo Hospitalario de Navarra Not yet recruiting
Pamplona, Navarra, Spain
Contact: Cristina Rodriguez, PhD         
Hospital Galdakao -Usansolo Recruiting
Usansolo, Vizcaya, Spain
Contact: Jose Luis Cabriada, PhD         
Hospital Universitario Central de Asturias Not yet recruiting
Asturias, Spain
Contact: Sabino Riesta, PhD         
Hospital Universitario Morales Meseguer Not yet recruiting
Murcia, Spain
Contact: Emilio Torrella, PhD         
Hospital Universitari La Fe Not yet recruiting
Valencia, Spain
Contact: Pilar Nos, PhD         
Sponsors and Collaborators
Javier P. Gisbert
Grupo Español de trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)
Investigators
Principal Investigator: Javier P Gisbert, MD PhD 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.

Responsible Party: Javier P. Gisbert, MD PhD, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier: NCT02686892     History of Changes
Other Study ID Numbers: GIS-2015-INCIDENCIA
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Javier P. Gisbert, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa:
Inflamatory bowel disease
Crohns disease
ulcerative colitis
incidence
epidemiology

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis