Clinical trial NCT03668249: A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
Official title: Characterization of a Multidimensional Model to Predict the Course of Crohn's Disease: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-09-12
Enrollment: 5938
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with CD, will be observed retrospectively.

Brief summary: The descriptive purpose of this study is to characterize clinical and nonclinical factors of participants with CD, participant flow and visits to other specialists in the hospitals of the healthcare network of the Autonomous Community of Madrid with implementation of electronic medical records. The clinical and nonclinical factors include: demographic and baseline clinical characteristics, lifestyle, relapses, complications, day hospital visits, surgery, presence of complications such as perianal fistulas and complex perianal fistulas. The predictive purpose of this study is to develop a statistical predictive model with the information obtained from the descriptive purpose, in the hospitals of the healthcare network of the Autonomous Community of Madrid, capable of assigning any participant diagnosed with CD a probability of reaching a prototypical clinical condition or a probability of experiencing certain clinical complications.

Detailed description: This is a retrospective and non-interventional study of participants with CD. The study will collect data from electronic medical records (EMRs) of the participants in the hospitals of the healthcare network of the Autonomous Community of Madrid with implementation of EMRs and will describe the determining factors and develop a statistical model for predicting likely outcomes in participants with CD. This study will conduct an additional substudy to evaluate the performance of the system through a human assessment to be performed by the clinical experts at each participating site.

The study will have a retrospective data collection from EMRs of the participants referring to last 5 years.

The study will enroll approximately 3000 participants. All participants will be enrolled in one observational cohort.

This multi-center trial will be conducted in Spain. The overall time for data collection in the study will be approximately 5 years.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with CD from the medical centers participating in the study.

Primary outcomes:
measure: Number of Participants who had Relapses
timeFrame: Approximately 5 years
measure: Number of Participants who had Disease Related Complications
timeFrame: Approximately 5 years
measure: Number of day Hospital Visits
timeFrame: Approximately 5 years
measure: Number of Participants who had Surgeries
timeFrame: Approximately 5 years
measure: Number of Participants with Complications Such as Perianal Fistulas and Complex Perianal Fistulas
timeFrame: approximately 5 years
measure: Participant Flow
timeFrame: Approximately 5 years
measure: Number of Participants who Visit to Other Specialists
timeFrame: Approximately 5 years
Secondary outcomes:
measure: Prevalence of the Different Phenotypes
timeFrame: Approximately 5 years
measure: Number of Participants who met the Eligibility Criteria to Receive Biological Treatment for CD
timeFrame: Approximately 5 years
measure: Number of Direct and Indirect Resources Used
timeFrame: Approximately 5 years
measure: Number of Essential Factors on Which Physician's Predictions of Participant Outcomes are Based
timeFrame: Approximately 5 years
Other outcomes:
Locations:
city: Boadilla
country: Spain
facility: HM Hospitales
state: Madrid
city: Fuenlabrada
country: Spain
facility: H. U. de Fuenlabrada
state: Madrid
city: Majadahonda
country: Spain
facility: H.U. Puerta de Hierro - Majadahonda
state: Madrid
city: Mostoles
country: Spain
facility: H.U. Rey Juan Carlos
state: Madrid
city: San Sebastian de Los Reyes
country: Spain
facility: H.U. Infanta Sofia
state: Madrid
city: Valdemoro
country: Spain
facility: H. U. Infanta Elena
state: Madrid
city: Vallecas
country: Spain
facility: H Infanta Leonor y Virgen de la Torre
state: Madrid
city: Madrid
country: Spain
facility: H La Princesa
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Gomollon F, Gisbert JP, Guerra I, Plaza R, Pajares Villarroya R, Moreno Almazan L, Lopez Martin MC, Dominguez Antonaya M, Vera Mendoza MI, Aparicio J, Martinez V, Tagarro I, Fernandez-Nistal A, Lumbreras S, Mate C, Montoto C; Premonition-CD Study Group. Clinical characteristics and prognostic factors for Crohn's disease relapses using natural language processing and machine learning: a pilot study. Eur J Gastroenterol Hepatol. 2022 Apr 1;34(4):389-397. doi: 10.1097/MEG.0000000000002317.