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

NCT ID: NCT04844593

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-08

Study Completion Date

2024-04-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Crohn Disease Rectal Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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 data will be collected retrospectively from January 1st 2015 and December 31st 2021.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1\. CD participant diagnosed or not with CPF between January 1st 2015 and December 31st 2021.

Exclusion Criteria

Not applicable.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Hospital Universitario Son Espases

Palma, Balearic Islands, Spain

Site Status

Hospital del Mar

Barcelona, Catalonia, Spain

Site Status

Hospital Universitario Fundacion Alcorcon

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Related Links

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https://clinicaltrials.takeda.com/study-detail/60774675688ad8001f42fba3

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

Other Identifiers

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Darvadstrocel-5001

Identifier Type: -

Identifier Source: org_study_id

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