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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A (preclinical IBD) | asymptomatic patients with a new diagnosis of IBD during the colorectal cancer screening programme meeting all inclusion and none of the exclusion criteria (n=350). |
| |
| Cohort B (control) | new-onset symptomatic IBD (n=80) - patients with a symptomatic debut of IBD in the last 3 months, naïve to immunosuppressants and biologic agents. |
| |
| Cohort C (control) | healthy controls (n=20): patients with a normal screening colonoscopy, with no signs of IBD after a detailed evaluation of the ileum and colon, will be included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bioespecimen samples | Procedure | Blood, serum, plasma, urine, stools, small/large bowel tissue. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease progression | Development and type of new-onset symptoms during follow-up (mainly diarrhea, abdominal pain, and rectal bleeding). | 10 years |
| Disease progression | Time to development of symptomatic disease during follow-up. | 10 years |
| - IBD characteristics |
| 10 years |
| Omic findings | proteomic, transcriptomic, serologic, microbiota, and tissue data | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| IBD characteristics: |
|
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Inclusion criteria
Patients from cohort A will be included if they fulfill all the following inclusion criteria:
Patients from cohort B will be included if they fulfill all the following inclusion criteria:
Patients from cohort C will be included if they fulfill all the following inclusion criteria:
Exclusion criteria
Patients from cohort A will be excluded if they fulfill any the following exclusion criteria:
Patients from cohort B will be excluded if they fulfill any the following exclusion criteria:
- Previous use of immunomodulators or biologics for any condition.
Patients from cohort C will be excluded if they fulfill any the following exclusion criteria:
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All patients with a new diagnosis of IBD
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erika Araya, PhD | Contact | +34 674682070 | secretariacientifica3@geteccu.org | |
| Iago Rodriguez Lago, MD | Contact | +34 674682070 | iago.r.lago@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Iago Rodriguez Lago, MD | Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Universitario de Santiago | Recruiting | Santiago de Compostela | A Coruña | 15706 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40365077 | Result | Rodriguez-Lago I, Marigorta UM, Mateos B, Manosa M, Marquez-Mosquera L, Menchen L, Rodriguez-Moranta F, Alonso I, Aguas M, Alonso-Galan H, Borras P, Castro B, Domenech E, Ferreiro-Iglesias R, de Francisco R, Garcia-Alonso FJ, Garcia N, Garcia-Bosch O, Gargallo C, Gisbert JP, Iglesias E, Mesonero F, Ortiz de Zarate J, Ramos L, Sainz E, Ladron P, Suria C, Ferrer CS, Tejido C, Varela P, Vicente R, Zabana Y, Castany G, Rodriguez E, Gutierrez A, Barreiro-de Acosta M. Natural history, immunological and genetic characteristics of preclinical inflammatory bowel disease (EARLY): study protocol for a prospective cohort study. Ther Adv Gastroenterol. 2025 May 12;18:17562848251338647. doi: 10.1177/17562848251338647. eCollection 2025. |
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Blood, serum, plasma, urine, stools, small/large bowel tissue.
| 10 years |
| Changes in endoscopic features during follow-up | 10 years |
| Microscopic characteristics at diagnosis | 10 years |
| Clinical disease activity during follow-up | 10years |
| Development and time to development of need for medical or surgical therapy during follow-up | 10years |
| Development and time to development of extraintestinal manifestations during follow-up | 10years |
| Type of extraintestinal manifestations during follow-up | 10years |
| Hospital Universitario Germans Trias i Pujol | Not yet recruiting | Badalona | Barcelona | 08916 | Spain |
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| Althaia, Xarxa Assistencial Universitària de Manresa | Not yet recruiting | Manresa | Barcelona | 08243 | Spain |
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| Hospital Universitari Mútua de Terrassa | Not yet recruiting | Terrassa | Barcelona | 08221 | Spain |
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| Hospital Universitario Donostia | Not yet recruiting | Donostia / San Sebastian | Gipuzkoa | 20014 | Spain |
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| Hospital Álvaro Cunqueiro (Complejo Hospitalario Universitario de Vigo) | Not yet recruiting | Vigo | Pontevedra | 36312 | Spain |
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| Hospital Universitario de Cabueñes | Recruiting | Gijón | Principality of Asturias | 33394 | Spain |
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| Hospital Universitario Central de Asturias | Not yet recruiting | Oviedo | Principality of Asturias | 33011 | Spain |
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| Hospital Universitario de Canarias | Not yet recruiting | San Cristóbal de La Laguna | Santa Cruz De Tenerife | 38320 | Spain |
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| Hospital Universitario de Galdakao | Recruiting | Galdakao | Vizcaya | 48960 | Spain |
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| Hospital General Universitario Dr. Balmis | Recruiting | Alicante | 03010 | Spain |
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| Hospital de Sant Joan Despí Moisès Broggi | Recruiting | Barcelona | 08970 | Spain |
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| Hospital Universitario de Basurto | Recruiting | Bilbao | 48013 | Spain |
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| Hospital Universitario de Burgos | Not yet recruiting | Burgos | 09006 | Spain |
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| Hospital Universitario Reina Sofía | Not yet recruiting | Córdoba | 14004 | Spain |
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| Hospital Universitario de la Princesa | Not yet recruiting | Madrid | 28006 | Spain |
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| Hospital General Universitario Gregorio Marañón | Active, not recruiting | Madrid | 28007 | Spain |
| Hospital Universitario Ramon y Cajal | Not yet recruiting | Madrid | 28034 | Spain |
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| Hospital Universitario La Paz | Not yet recruiting | Madrid | 28046 | Spain |
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| Complejo Hospitalario Universitario de Ourense | Not yet recruiting | Ourense | 32005 | Spain |
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| Hospital Universitario Clínico de Valencia | Not yet recruiting | Valencia | 46010 | Spain |
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| Hospital Univeristario y Politécnico La Fe | Not yet recruiting | Valencia | 46026 | Spain |
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| Hospital Universitario Río Hortega | Not yet recruiting | Valladolid | 47012 | Spain |
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| Hospital Clínico Universitario Lozano Blesa | Not yet recruiting | Zaragoza | 50009 | Spain |
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| Hospital Universitario Miguel Servet | Not yet recruiting | Zaragoza | 50009 | Spain |
|
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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