A Study Using Artificial Intelligence to Identify Adults With Complex Perianal Fistulas Associated With Crohn's Disease

Crohn Disease Clinical Trial

— INTUITION-CPF  

Official title:

Use of Natural Language Processing (NLP) and Machine Learning (ML) for the Identification of Patients With Crohn's Disease (CD) and Complex Perianal Fistulas (CPF) and Their Characterization in Terms of Clinical and Demographic Characteristics. A Multicentre, Retrospective, NLP Based Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04844593
• Other study ID #: Darvadstrocel-5001
• Status: Recruiting
• Start date: March 8, 2022
• Est. completion date: February 29, 2024

Study information

• Verified date: January 2024
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Natural Language Processing and machine learning are examples of artificial intelligence tools. This study will check if these tools correctly identify people with Crohn's disease with complex perianal fistulas from their medical records.

Description:

This is a non-interventional, retrospective study of participants with CD and CPF in a clinical practice setting. The study will enroll approximately 100 participants. The study will have a retrospective data collection to select and analyze information from EMRs processed by an AI based analytics framework that uses machine learning and NLP methodologies. All participants will be enrolled in one observational group. • Participants with CD This multi-center trial will be conducted in Spain. The overall duration of the study is approximately 36 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: February 29, 2024
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. CD participant diagnosed or not with CPF between January 1st 2015 and December 31st 2021. Exclusion Criteria: Not applicable.

Related Conditions & MeSH terms

• Crohn Disease
• Fistula
• Rectal Fistula

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona	Cataluna
Spain	Hospital Universitario Fundacion Alcorcon	Madrid	Comunidad De Madrid
Spain	Hospital Universitario Son Espases	Palma	Islas Baleares

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With CD and CPF Accurately Identified With the use of NLP and Medical Language (MEL)	Percentage of participants will be measured in terms of accuracy and precision (sensitivity and specificity) of the "algorithm" used to identify participants with CPF associated with CD. Data obtained through the artificial intelligence (AI) technology will be compared with data obtained through traditional electronic data capture (EDC) and source data verification methods.	Up to Month 36
Secondary	Number of Participants With CD and CPF Characterized Using NLP and Machine Learning Techniques	The following information at the moment of CPF diagnosis will be extracted from the electronical medical records (EMRs): age, gender, date of diagnosis of CPF, smoking status, date of diagnosis of CD, luminal disease characteristics (localization, behaviour and activity) at diagnosis, treatments (medical and surgical) established for luminal disease in the study period, treatments (medical and surgical) established for CPF since first occurrence, fistula characteristics at diagnosis: type of fistula (following American Gastroenterological Association [AGA] classification) number of fistula internal and external openings, fistula activity.	Up to Month 36

External Links

•   To obtain more information on the study, click here/on this link