Crohn DiseaseINTUITION-CPFNCT04844593
A Study Using Artificial Intelligence to Identify Adults With Complex Perianal Fistulas Associated With Crohn's Disease
An observational study of Crohn Disease and Rectal Fistula, run by Takeda at 3 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Rectal Fistula
- How many people
- 32 participants
- Where
- 3 sitesSpain
- Study dates
- 8 Mar 2022to 29 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with CD diagnosed with or without CPF during the study period.
Who may be able to join
- 1. CD participant diagnosed or not with CPF between January 1st 2015 and December 31st 2021.
Who cannot join
- Not applicable.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital del Mar
Barcelona, Catalonia, 08003
Hospital Universitario Fundacion Alcorcon
Madrid, Madrid, 28922
Hospital Universitario Son Espases
Palma, Balearic Islands, 07010
About this study
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
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.
Read the detailed 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.
- Conditions
- Crohn Disease, Rectal Fistula
- Keywords
- Drug Therapy
- Medical subject headings
- Crohn Disease, Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Month 36
Secondary outcomes (1)
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.
Measured: Up to Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start8 Mar 2022
- Primary completion27 Feb 2023
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844593
- Sponsor's protocol ID
- Darvadstrocel-5001
- Acronym
- INTUITION-CPF
- Status last verified
- May 2024
- First submitted
- 13 Apr 2021
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04844593
- Acronym / sponsor ID
- INTUITION-CPF / Darvadstrocel-5001
- Conditions
- Crohn Disease, Rectal Fistula
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with CD diagnosed with or without CPF during the study period.
Key inclusion criteria (1 listed)
- 1. CD participant diagnosed or not with CPF between January 1st 2015 and December 31st 2021.
Key exclusion criteria (1 listed)
- Not applicable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants With CD and CPF Accurately Identified With the use of NLP and Medical Language (MEL)
Time frame: Up to Month 36
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.
1 secondary outcome
Number of Participants With CD and CPF Characterized Using NLP and Machine Learning Techniques
Time frame: Up to Month 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Rectal Fistula, run by Takeda at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With CD and CPF Accurately Identified With the use of NLP and Medical Language (MEL) (time frame: Up to Month 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.