An observational study in Crohn Disease and Rectal Fistula, sponsored by Takeda. Completed at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by Takeda · Observational
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.
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.
This multi-center trial will be conducted in Spain. The overall duration of the study is approximately 36 months.
1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.
This study's enrollment of 32 is below the median of 166 across 624 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Takeda is the lead sponsor of 1,025 studies on the registry; 92 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 153 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with CD diagnosed with or without CPF during the study period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. CD participant diagnosed or not with CPF between January 1st 2015 and December 31st 2021.
Exclusion Criteria:
Not applicable.
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.
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.
Time frame: Up to Month 36
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.
Time frame: Up to Month 36
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Data sharing details ↗ · vivli.org
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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