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

NCT03689257 | Completed

• 1 other identifier: GIS-2016-IBDomics
• Study Type: observational
• Target: 376
• Locations: 1 country
• Sites: 16

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

Conditions

Inflammatory Bowel Diseases

Keywords

inflammatory bowel disease; Ulcerative colitis; Crohn´s disease; epidemiology; incidence; omics

Outcome Measures

Primary Outcomes (1)

• Incidence of IBD in Spain

  Measure the incidence of IBD in Spain

  1 year

Secondary Outcomes (4)

• Characteristics of patients at diagnosis of inflammatory bowel disease and resources used in the first year after diagnosis

  1 year

• Create a wide collection of samples

  1 year

• Identify the molecular and cellular pathways involved with IBD development and pathogenesis.

  1 year

• Correlate the serum proteomic profile and the density

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients recently diagnosed of inflammatory bowel disese who have not initiated a treatment to IBD

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: lead

Study Sites (16)

Hospital Universitario Mutua Terrasa

Terrassa, Barcelona, 08221, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

Hospital Universitario Santiago de Compostela

Santiago de Compostela, Santiago de Comostela, 15706, Spain

Location

Hospital de Galdakao

Galdakao, Vizcaya, 48960, Spain

Location

Hospital General universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Universitario de Ciudad Real

Ciudad Real, 13005, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital San Jorge

Huesca, 22004, Spain

Location

Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, 35020, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Morale Mesenguer

Murcia, 30008, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, 07010, Spain

Location

Hospital Universitaro Marqués de Valdecilla

Santander, 39008, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

Location

Hospital Clínico Univesitario de Valladolid

Valladolid, 47005, Spain

Location

Related Publications (52)

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Biospecimen

Retention: SAMPLES WITH DNA

Samples of blood, urine simple and stool sample

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: October 1, 2017
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

ES (16)