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Advanced Data-Aided Medicine Part Lung Cancer

ADAM Substudy Luik 2: Observational Retrospective Single Centre Cohort Study on Constructing & Validating AI Prediction Models for Outcomes of Lung Cancer Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05783024
Acronym
ADAMpartlung
Enrollment
500
Registered
2023-03-24
Start date
2021-09-27
Completion date
2024-12-31
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

AI, ML, Lung Cancer, Prediction

Brief summary

Developing and validating an AI model that supports physicians in their decision process for treating lung cancer patients. This AI model needs to predict the probability of (the evolution of) the outcomes, based on clinical data and a simulated lung cancer treatment plan. The outcome probabilities can be evaluated with different treatment plans to identify the optimal plan. Initially, the input data will be a limited set of selected features such as general patient information, tumour characteristics, laboratory measurement results, comorbidities and treatments. Finally, the goal is to use a deep patient as input to the models.This deep patient is an AI model on its own, trained on hospital data, as described in secondary objectives.

Detailed description

The aim of this study is to prepare and unlock siloed real-world-data (RWD) for analysis and artificial model construction with the goal to derive real-world-evidence (RWE). Nowadays physicians and nurses are gathering data from patients and register the data in the electronic health record system. Datapoints are often not available in a structured format, so data gathering and unlocking is done manually upon request. Careful analysis of the collected data using artificial intelligence tools might also help to predict which patients are at the highest risk of unscheduled health care use, emergency department visits and hospital admissions. Therefore, a model able to predict the relevant outcomes would be of significant help to the physicians' daily practice. Primary Objective Developing and validating an AI model that supports physicians in their decision process for treating lung cancer patients. This AI model needs to predict the probability (of the evolution) of the outcomes, based on clinical data and a simulated lung cancer treatment plan and later on a deep patient. Model input data sources are hospital data like demographics, baseline health status, prior treatments, tumour characteristics, comorbidities , imaging data & physiological data, detailed treatment data. Secondary Objectives * Automatic unlocking, collection & transformation of lung cancer datapoints to OMOP common data model so that data is readily available for further research & analysis * Training and validating supervised machine learning models with a limited feature set as input to predict lung cancer patient outcomes * Constructing a digital patient by training an AI model fed with all data available in OMOP common data model * Validating a digital patient & optimal feature selection to enhance AI model performance via unsupervised learning techniques The potential of applying transformers to represent patients is truly personalized and even predictive medicine. The reason is that transformers are an instrument which make it possible to deal with millions of interacting and non-linearly behaving parameters. Hence data sources can be extended to include genetic information and so on. Optimal feature selection from a digital patient can enhance AI model performance via unsupervised learning techniques, and so further finetune prediction models for daily practice. To build a virtual twin to represent a patient in detail so population analysis and model building is clinically relevant.

Interventions

OTHERData collection

retrospective data collection

Sponsors

AZ Delta
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Lung cancer patients included in the lung cancer patient pathway

Exclusion criteria

* None specified

Design outcomes

Primary

MeasureTime frameDescription
Data into international common data model ready for AI input2022Lung cancer hospital data translated and clinically validated in UMLS concepts and stored in the OMOP common data model

Secondary

MeasureTime frameDescription
Supervised machine learning2023Training and validating supervised machine learning models with a limited set of selected features as input to predict lung cancer patient outcomes.
Digital patient construction2023Constructing a digital patient by training an AI model
Construction & validation of predictive AI model for lung cancer patients2024Construction & validation of predictive AI model feasibility approach; Constructing predicted outcome AI models like 30 day mortality, 30- day ER visit, QoL evolution, acute treatment complications

Countries

Belgium

Contacts

Primary ContactPeter De Jaeger, PhD
peter.dejaeger@azdelta.be003251237650
Backup ContactIngel Demedts, MD
003251237111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026