A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)

NCT ID: NCT03668249

Last Updated: 2019-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5938 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-26
• Study Completion Date: 2019-09-16

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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

All Participants

Participants diagnosed with CD from approximately 12 to 15 investigational sites will be observed retrospectively for previous 5 years.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

HM Hospitales

Boadilla, Madrid, Spain

H. U. de Fuenlabrada

Fuenlabrada, Madrid, Spain

H.U. Puerta de Hierro - Majadahonda

Majadahonda, Madrid, Spain

H.U. Rey Juan Carlos

Móstoles, Madrid, Spain

H.U. Infanta Sofia

San Sebastián de los Reyes, Madrid, Spain

H. U. Infanta Elena

Valdemoro, Madrid, Spain

H Infanta Leonor y Virgen de la Torre

Vallecas, Madrid, Spain

H La Princesa

Madrid, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 34882644 (View on PubMed)

Other Identifiers

U1111-1220-0873

Identifier Type: REGISTRY

Identifier Source: secondary_id

IBD-5002

Identifier Type: -

Identifier Source: org_study_id