Natural history, immunological and genetic characteristics of preclinical inflammatory bowel disease (EARLY): study protocol for a prospective cohort study
Background: The period prior to the diagnosis of inflammatory bowel disease (IBD), defined as the preclinical phase, has emerged as a potential target for disease modification strategies. Despite the relevance of an early diagnosis to the prognosis of the disease, only a limited number of patients a...
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SAGE Publishing
2025-05-01
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| Series: | Therapeutic Advances in Gastroenterology |
| Online Access: | https://doi.org/10.1177/17562848251338647 |
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| author | Iago Rodríguez-Lago Urko M. Marigorta Beatriz Mateos Míriam Mañosa Lucía Márquez-Mosquera Luis Menchén Francisco Rodríguez-Moranta Inmaculada Alonso Mariam Aguas Horacio Alonso-Galán Pere Borràs Beatriz Castro Eugeni Domènech Rocío Ferreiro-Iglesias Ruth de Francisco Francisco Javier García-Alonso Natalia García Orlando García-Bosch Carla Gargallo Javier P. Gisbert Eva Iglesias Francisco Mesonero Jone Ortiz de Zárate Laura Ramos Empar Sáinz Pablo Ladrón Carles Suria Cristina Suárez Ferrer Coral Tejido Pilar Varela Raquel Vicente Yamile Zabana Gisela Castany Eva Rodríguez Ana Gutiérrez Manuel Barreiro-de Acosta |
| author_facet | Iago Rodríguez-Lago Urko M. Marigorta Beatriz Mateos Míriam Mañosa Lucía Márquez-Mosquera Luis Menchén Francisco Rodríguez-Moranta Inmaculada Alonso Mariam Aguas Horacio Alonso-Galán Pere Borràs Beatriz Castro Eugeni Domènech Rocío Ferreiro-Iglesias Ruth de Francisco Francisco Javier García-Alonso Natalia García Orlando García-Bosch Carla Gargallo Javier P. Gisbert Eva Iglesias Francisco Mesonero Jone Ortiz de Zárate Laura Ramos Empar Sáinz Pablo Ladrón Carles Suria Cristina Suárez Ferrer Coral Tejido Pilar Varela Raquel Vicente Yamile Zabana Gisela Castany Eva Rodríguez Ana Gutiérrez Manuel Barreiro-de Acosta |
| author_sort | Iago Rodríguez-Lago |
| collection | DOAJ |
| description | Background: The period prior to the diagnosis of inflammatory bowel disease (IBD), defined as the preclinical phase, has emerged as a potential target for disease modification strategies. Despite the relevance of an early diagnosis to the prognosis of the disease, only a limited number of patients are diagnosed during this window of opportunity. Objectives: To determine the risk of developing symptoms after an incidental diagnosis of IBD and to describe the clinical, genetic, and immunological characteristics of IBD during its preclinical phase. Design: This study protocol describes a prospective, multicenter cohort study in which incidental (i.e., asymptomatic) IBD within the colorectal cancer screening program will be characterized from a clinical and multi-omic perspective and compared with symptomatic patients and healthy non-IBD controls. Methods: Samples from blood, urine, stool, and intestinal endoscopic biopsies will be obtained at baseline. A second sample set will be obtained after 52 weeks from those who remain asymptomatic; samples will also be obtained in those with new-onset symptoms. Medical treatment will be prescribed in all patients following current guidelines. Follow-up visits will be performed every 6 months for 10 years, and all new-onset symptoms, changes in disease behavior, extraintestinal manifestations, IBD-related medical therapies, or surgeries will be recorded. Two control cohorts will be included: one including recently diagnosed symptomatic IBD patients (<3 months), and another with healthy non-IBD controls after a normal ileocolonoscopy, in whom samples will be obtained at baseline. Samples from patients and controls will undergo genetic, proteomic, transcriptomic, single-cell RNA sequencing, metabolomic, and microbiome analyses, and integration of data between the different omic perspectives will also be performed. The study has been approved by the Basque Country Ethics Committee (PI2021116). Conclusion: EARLY will generate a unique dataset addressing a previously unexplored area of IBD, with the final aim of describing the prognosis of patients from its earlier phases on the disease and integrating clinical and omic data into useful tools for the long-term prediction of disease outcomes. Trial registration: NCT05698745. |
| format | Article |
| id | doaj-art-0e3c6a39bf454d7c98d0e1c756d71042 |
| institution | DOAJ |
| issn | 1756-2848 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Gastroenterology |
| spelling | doaj-art-0e3c6a39bf454d7c98d0e1c756d710422025-08-20T02:58:41ZengSAGE PublishingTherapeutic Advances in Gastroenterology1756-28482025-05-011810.1177/17562848251338647Natural history, immunological and genetic characteristics of preclinical inflammatory bowel disease (EARLY): study protocol for a prospective cohort studyIago Rodríguez-LagoUrko M. MarigortaBeatriz MateosMíriam MañosaLucía Márquez-MosqueraLuis MenchénFrancisco Rodríguez-MorantaInmaculada AlonsoMariam AguasHoracio Alonso-GalánPere BorràsBeatriz CastroEugeni DomènechRocío Ferreiro-IglesiasRuth de FranciscoFrancisco Javier García-AlonsoNatalia GarcíaOrlando García-BoschCarla GargalloJavier P. GisbertEva IglesiasFrancisco MesoneroJone Ortiz de ZárateLaura RamosEmpar SáinzPablo LadrónCarles SuriaCristina Suárez FerrerCoral TejidoPilar VarelaRaquel VicenteYamile ZabanaGisela CastanyEva RodríguezAna GutiérrezManuel Barreiro-de AcostaBackground: The period prior to the diagnosis of inflammatory bowel disease (IBD), defined as the preclinical phase, has emerged as a potential target for disease modification strategies. Despite the relevance of an early diagnosis to the prognosis of the disease, only a limited number of patients are diagnosed during this window of opportunity. Objectives: To determine the risk of developing symptoms after an incidental diagnosis of IBD and to describe the clinical, genetic, and immunological characteristics of IBD during its preclinical phase. Design: This study protocol describes a prospective, multicenter cohort study in which incidental (i.e., asymptomatic) IBD within the colorectal cancer screening program will be characterized from a clinical and multi-omic perspective and compared with symptomatic patients and healthy non-IBD controls. Methods: Samples from blood, urine, stool, and intestinal endoscopic biopsies will be obtained at baseline. A second sample set will be obtained after 52 weeks from those who remain asymptomatic; samples will also be obtained in those with new-onset symptoms. Medical treatment will be prescribed in all patients following current guidelines. Follow-up visits will be performed every 6 months for 10 years, and all new-onset symptoms, changes in disease behavior, extraintestinal manifestations, IBD-related medical therapies, or surgeries will be recorded. Two control cohorts will be included: one including recently diagnosed symptomatic IBD patients (<3 months), and another with healthy non-IBD controls after a normal ileocolonoscopy, in whom samples will be obtained at baseline. Samples from patients and controls will undergo genetic, proteomic, transcriptomic, single-cell RNA sequencing, metabolomic, and microbiome analyses, and integration of data between the different omic perspectives will also be performed. The study has been approved by the Basque Country Ethics Committee (PI2021116). Conclusion: EARLY will generate a unique dataset addressing a previously unexplored area of IBD, with the final aim of describing the prognosis of patients from its earlier phases on the disease and integrating clinical and omic data into useful tools for the long-term prediction of disease outcomes. Trial registration: NCT05698745.https://doi.org/10.1177/17562848251338647 |
| spellingShingle | Iago Rodríguez-Lago Urko M. Marigorta Beatriz Mateos Míriam Mañosa Lucía Márquez-Mosquera Luis Menchén Francisco Rodríguez-Moranta Inmaculada Alonso Mariam Aguas Horacio Alonso-Galán Pere Borràs Beatriz Castro Eugeni Domènech Rocío Ferreiro-Iglesias Ruth de Francisco Francisco Javier García-Alonso Natalia García Orlando García-Bosch Carla Gargallo Javier P. Gisbert Eva Iglesias Francisco Mesonero Jone Ortiz de Zárate Laura Ramos Empar Sáinz Pablo Ladrón Carles Suria Cristina Suárez Ferrer Coral Tejido Pilar Varela Raquel Vicente Yamile Zabana Gisela Castany Eva Rodríguez Ana Gutiérrez Manuel Barreiro-de Acosta Natural history, immunological and genetic characteristics of preclinical inflammatory bowel disease (EARLY): study protocol for a prospective cohort study Therapeutic Advances in Gastroenterology |
| title | Natural history, immunological and genetic characteristics of preclinical inflammatory bowel disease (EARLY): study protocol for a prospective cohort study |
| title_full | Natural history, immunological and genetic characteristics of preclinical inflammatory bowel disease (EARLY): study protocol for a prospective cohort study |
| title_fullStr | Natural history, immunological and genetic characteristics of preclinical inflammatory bowel disease (EARLY): study protocol for a prospective cohort study |
| title_full_unstemmed | Natural history, immunological and genetic characteristics of preclinical inflammatory bowel disease (EARLY): study protocol for a prospective cohort study |
| title_short | Natural history, immunological and genetic characteristics of preclinical inflammatory bowel disease (EARLY): study protocol for a prospective cohort study |
| title_sort | natural history immunological and genetic characteristics of preclinical inflammatory bowel disease early study protocol for a prospective cohort study |
| url | https://doi.org/10.1177/17562848251338647 |
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