ClinicalTrials.gg
RecruitingNCT05783024ADAMpartlungUpdated May 10, 2023

Advanced Data-Aided Medicine Part Lung Cancer

An observational study in Lung Cancer, sponsored by AZ Delta. Recruiting at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2023-05-10.

Sponsored by AZ Delta · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
  • Started Sep 2021; still recruiting 5 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
500
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Cancer

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Keywords

  • AI
  • ML
  • Lung Cancer
  • Prediction
03

In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

AZ Delta is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Lung cancer patients included in the lung cancer patient pathway from 20/04/2018

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.

Inclusion criteria

  • Lung cancer patients included in the lung cancer patient pathway

Exclusion criteria

Exclusion Criteria:

  • None specified
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Interventions

  • OtherData collection

    retrospective data collection

06

What researchers measure

Primary outcomes

  1. Data into international common data model ready for AI input

    Lung cancer hospital data translated and clinically validated in UMLS concepts and stored in the OMOP common data model

    Time frame: 2022

Secondary outcomes

  1. Supervised machine learning

    Training and validating supervised machine learning models with a limited set of selected features as input to predict lung cancer patient outcomes.

    Time frame: 2023

  2. Digital patient construction

    Constructing a digital patient by training an AI model

    Time frame: 2023

  3. Construction & validation of predictive AI model for lung cancer patients

    Construction \& 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

    Time frame: 2024

07

Study locations

1 of 1 sites recruiting
  • AZ Delta
    Roeselare, West-Vlaanderen 8800, Belgium
    Recruiting
    • Peter De Jaeger, PhD, Prof · Contactpeter.dejaeger@azdelta.be · 003251237650
    • Ingel Demedts, Prof · Principal investigator
    • Hannelore Bode, MD · Sub investigator
    • Bernard Bouckaerts, MD · Sub investigator
    • Kris Carron, MD · Sub investigator
    • Stephanie Dobbelaere, MD · Sub investigator
    • Ulrike Himpe, MD · Sub investigator
    • Heidi Mariën, MD · Sub investigator
    • Peter Van Haecke, MD · Sub investigator
    • Wim Verbeke, MD · Sub investigator
    • Peter De Jaeger, Prof, PhD · Sub investigator
    • Pieter-Jan Lammertyn · Sub investigator
    • Louise Berteloot · Sub investigator
    • Kim Denturck, Msc ir · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05783024
Lead sponsor
AZ Delta
Responsible party
Sponsor
First posted
Mar 24, 2023
Start date
Sep 27, 2021
Primary completion
Sep 27, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
May 10, 2023

Study contacts

Peter De Jaeger, PhD
Contact
peter.dejaeger@azdelta.be
003251237650
Ingel Demedts, MD
Contact
003251237111
Ingel Demedts, MD
principal investigator · AZ Delta

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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