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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. CD participant diagnosed or not with CPF between January 1st 2018 and December 31st 2019.

Exclusion Criteria:

Not applicable.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04844593
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Takeda
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Study Director
Principal Investigator Affiliation Takeda
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease, Rectal Fistula
Study Website: View Trial Website
Additional Details

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. The study will be structured in two sequential phases: Phase 1 (validation process) and Phase 2 (data collection and NLP). 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 21 months.

Arms & Interventions

Arms

: Participants With CD

Participants with CD diagnosed with or without CPF will be identified from EMRs through medical language application program interface (API) software. The AI will apply NLP and machine learning to identify and analyse text information in EMRs and thereby, extract medical information. The study will consist of two sequential phases: Phase 1 (validation process) and Phase 2 (data collection and NLP).

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hospital del Mar, Barcelona, Cataluna, Spain

Status

Not yet recruiting

Address

Hospital del Mar

Barcelona, Cataluna, 08003

Site Contact

Site Contact

lmarquez@psmar.cat

932483217

Hospital Universitario de La Princesa, Madrid, Comunidad De Madrid, Spain

Status

Not yet recruiting

Address

Hospital Universitario de La Princesa

Madrid, Comunidad De Madrid, 28006

Site Contact

Site Contact

javier.p.gisbert@gmail.com

913093911

Madrid, Comunidad De Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Fundacion Alcorcon

Madrid, Comunidad De Madrid, 28922

Site Contact

Site Contact

joselazaro.perez@salud.madrid.org

654583098

Hospital Universitario Son Espases, Palma, Islas Baleares, Spain

Status

Recruiting

Address

Hospital Universitario Son Espases

Palma, Islas Baleares, 07010

Site Contact

Site Contact

xavier.gonzalez@ssib.es

internal: 75458

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