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
2 other identifiers
observational
5,938
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedStudy Start
First participant enrolled
September 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2019
CompletedOctober 3, 2019
October 1, 2019
12 months
September 11, 2018
October 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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 Outcomes (4)
Prevalence of the Different Phenotypes
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
Approximately 5 years
Number of Essential Factors on Which Physician's Predictions of Participant Outcomes are Based
Approximately 5 years
Study Arms (1)
All Participants
Participants diagnosed with CD from approximately 12 to 15 investigational sites will be observed retrospectively for previous 5 years.
Eligibility Criteria
Participants diagnosed with CD, will be observed retrospectively.
You may qualify if:
- \. Diagnosed with CD from the medical centers participating in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (8)
HM Hospitales
Boadilla, Madrid, 28660, Spain
H. U. de Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
H.U. Puerta de Hierro - Majadahonda
Majadahonda, Madrid, 28222, Spain
H.U. Rey Juan Carlos
Móstoles, Madrid, 28933, Spain
H.U. Infanta Sofia
San Sebastián de los Reyes, Madrid, 28703, Spain
H. U. Infanta Elena
Valdemoro, Madrid, 28342, Spain
H Infanta Leonor y Virgen de la Torre
Vallecas, Madrid, 28031, Spain
H La Princesa
Madrid, 28006, Spain
Related Publications (1)
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.
PMID: 34882644DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2018
First Posted
September 12, 2018
Study Start
September 26, 2018
Primary Completion
September 16, 2019
Study Completion
September 16, 2019
Last Updated
October 3, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will share
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.