The purpose of this study is to evaluate disease progression, in terms of development of symptomatic disease and complications associated with IBD (e.g. fistula, abscess, stricture).
This is a prospective, observational, multicenter, collaborative research project that will explore the earlier stages of IBD, before the onset of the first symptoms of the disease. This novel approach constitutes an innovative strategy on the research on the natural history of the disease. The study will be carried out based on colorectal cancer screening colonoscopies, recruiting all patients with a new diagnosis of IBD in this setting. These patients will undergo follow-up visits every 6 months for 10 years and the clinical information will be enriched with longitudinal multi-omic analyses. Two additional control groups will be identified, including patients with new-onset symptomatic IBD in the last 3 months and healthy controls (with normal screening colonoscopy).
Study Type
OBSERVATIONAL
Enrollment
450
Blood, serum, plasma, urine, stools, small/large bowel tissue.
Disease progression
Development and type of new-onset symptoms during follow-up (mainly diarrhea, abdominal pain, and rectal bleeding).
Time frame: 10 years
Disease progression
Time to development of symptomatic disease during follow-up.
Time frame: 10 years
- IBD characteristics
* Type (CD or UC) * Disease extent (CD or UC) according to Montreal classification * CD phenotype at diagnosis (Montreal classification) * Endoscopic characteristics at diagnosis (both CD and UC): type of lesions, distribution, and extent * Presence and type (simple, complex fistula or abscess) of perianal disease at diagnosis and during follow-up
Time frame: 10 years
Omic findings
proteomic, transcriptomic, serologic, microbiota, and tissue data
Time frame: 10 years
IBD characteristics:
* Development and time to development of changes in CD disease location, according to Montreal classification. * Development and time to development of new-onset or stricturing, penetrating or perianal complications, defined as changes in CD phenotype (Montreal classification) * Development of proximal disease extension in UC * Laboratory parameters: FOBT levels at diagnosis, and CRP, hemoglobin, albumin, fecal calprotectin at diagnosis and during follow-up.
Time frame: 10 years
Changes in endoscopic features during follow-up
Time frame: 10 years
Microscopic characteristics at diagnosis
Time frame: 10 years
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Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain
RECRUITINGHospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
NOT_YET_RECRUITINGAlthaia, Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, Spain
NOT_YET_RECRUITINGHospital Universitari Mútua de Terrassa
Terrassa, Barcelona, Spain
NOT_YET_RECRUITINGHospital Universitario Donostia
Donostia / San Sebastian, Gipuzkoa, Spain
NOT_YET_RECRUITINGHospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo)
Vigo, Pontevedra, Spain
NOT_YET_RECRUITINGHospital Universitario de Cabueñes
Gijón, Principality of Asturias, Spain
RECRUITINGHospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
NOT_YET_RECRUITINGHospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
NOT_YET_RECRUITINGHospital Universitario de Galdakao
Galdakao, Vizcaya, Spain
RECRUITING...and 15 more locations
Clinical disease activity during follow-up
Time frame: 10years
Development and time to development of need for medical or surgical therapy during follow-up
Time frame: 10years
Development and time to development of extraintestinal manifestations during follow-up
Time frame: 10years
Type of extraintestinal manifestations during follow-up
Time frame: 10years