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

Characterization of a Multidimensional Model to Predict the Course of Crohn's Disease: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Crohn Disease

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.

• Study Type: Observational
• Enrollment (Actual): 5938

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28006
    • H La Princesa
  • Madrid
    • Boadilla, Madrid, Spain, 28660
      • HM hospitales
    • Fuenlabrada, Madrid, Spain, 28942
      • H. U. de Fuenlabrada
    • Majadahonda, Madrid, Spain, 28222
      • H.U. Puerta de Hierro - Majadahonda
    • Mostoles, Madrid, Spain, 28933
      • H.U. Rey Juan Carlos
    • San Sebastian de Los Reyes, Madrid, Spain, 28703
      • H.U. Infanta Sofía
    • Valdemoro, Madrid, Spain, 28342
      • H. U. Infanta Elena
    • Vallecas, Madrid, Spain, 28031
      • H Infanta Leonor y Virgen de la Torre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with CD, will be observed retrospectively.

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants who had Relapses	Approximately 5 years
Number of Participants who had Disease Related Complications	Approximately 5 years
Number of day Hospital Visits	Approximately 5 years
Number of Participants who had Surgeries	Approximately 5 years
Number of Participants with Complications Such as Perianal Fistulas and Complex Perianal Fistulas	approximately 5 years
Participant Flow	Approximately 5 years
Number of Participants who Visit to Other Specialists	Approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of the Different Phenotypes	Development of a statistical predictive model capable of assigning any patient diagnosed with CD a probability of reaching a prototypical clinical condition or a probability of experiencing certain clinical complications.	Approximately 5 years
Number of Participants who met the Eligibility Criteria to Receive Biological Treatment for CD		Approximately 5 years
Number of Direct and Indirect Resources Used	Health care resources of participants with CD will be assessed in terms of direct and indirect resources. Direct resources will include number of hospital admissions, emergency and hospital visits, and tests performed, etc. Indirect resources related to decreased productivity of CD participants through a specific variable, the total number of work days lost due to CD during the study period.	Approximately 5 years
Number of Essential Factors on Which Physician's Predictions of Participant Outcomes are Based		Approximately 5 years

Collaborators and Investigators

• Sponsor: Takeda

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2018
• Primary Completion (Actual): September 16, 2019
• Study Completion (Actual): September 16, 2019

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Drug therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: IBD-5002; U1111-1220-0873 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No