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AI-based Predictive and Interventional System for Early Detection of Non-compliance Risks With Oral Therapies in Lymphoma Patients.

AI-based Predictive and Interventional System for Early Detection of Non-compliance Risks With Oral Therapies in Lymphoma Patients, Integrating the Complete Care Pathway and an Interoperable Clinical Interface With Algorithms Paired With Explainability Tools.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07546188
Acronym
LNH-AI-Tools
Enrollment
210
Registered
2026-04-22
Start date
2026-02-15
Completion date
2029-02-15
Last updated
2026-04-22

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

Conditions

Care Coordination, Lymphoma, Non-Hodgkin

Keywords

Artificial intelligence, Non-Hodgkin lymphoma, Care pathway

Brief summary

This research forms part of a continuous quality improvement initiative. It aims to assess patient compliance of oral therapies by artificial intelligence. It could overcome the limitations of current practices and enhance the responsiveness and accuracy of clinical interventions.

Detailed description

Non- Hodgkin Lymphomas require rigorous treatment protocols, including intensive intravenous chemotherapy or targeted oral therapies. Secondary immunosuppression necessitates oral anti-infective prophylaxis (such as valacyclovir or Bactrim forte) to prevent opportunistic complications. However, the literature reports figures of up to 50% of patients experiencing adherence difficulties on oral therapies, compromising treatment efficacy, increasing the risk of severe infections, prolonged hospitalizations, and consequently, additional costs for the healthcare system. This project proposes to develop an innovative artificial intelligence (AI) tool, based on real-world data, to detect early signs of non-adherence and enable targeted intervention by healthcare teams. Our approach combines analysis of clinical data (patient, disease, dispensing history, laboratory results, drug interactions) and machine learning algorithms (supervised machine learning and neural networks) to identify at-risk profiles. The tool will generate a real-time alert and offer the patient's referring physician and coordinating nurse tailored recommendations, such as an automated reminder, a dedicated nursing consultation, etc. An intuitive interface will allow clinicians and nurses to visualize compliance trends and act quickly. This project relies on a multidisciplinary team (hematologists, advanced practice nurses (APNs), data scientists, AI experts) and patient partners to validate the tool in real-world conditions.

Interventions

OTHERRetrospective Group

For the retrospective group of 20 patients.

Follow-up of the patients for the prospective group

Sponsors

Grand Hôpital de Charleroi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients aged 18 and over who are treated in the Haematology Department at the Grand Hôpital de Charleroi from November 2025 onwards * Treated for a lymphoma, Non Hodgkin * Capable of giving informed consent

Exclusion criteria

* All other patients who did not meet the eligibility criteria

Design outcomes

Primary

MeasureTime frameDescription
ROC-AUC2027Description: ROC-AUC : Receiver Operating Characteristic - Area Under the Curve is a performance metric for binary classification prediction algorithms. ROC Curve: Plots the True Positive Rate (sensitivity) against the False Positive Rate (1-specificity) at various classification thresholds. AUC: The area under this curve (ranging from 0 to 1). A higher AUC indicates better model performance-1.0 is perfect, 0.5 is random guessing. ROC-AUC evaluates how well the model distinguishes between classes, regardless of the classification threshold. Time Frame: When the data will be avalaible, at the end of 2027

Secondary

MeasureTime frameDescription
F1-scoreWhen the data will be avalaible, at the end of 2027F1-Score is a performance metric for classification algorithms, the harmonic mean of Precision (correct positive predictions / total positive predictions) and Recall (correct positive predictions / actual positives). Formula: F1 = 2 × (Precision × Recall) / (Precision + Recall) Range: 0 to 1, where 1 is perfect precision and recall, and 0 is the worst. F1-Score balances precision and recall, making it ideal when you need to avoid both false positives and false negatives.

Countries

Belgium

Contacts

CONTACTMarie Detrait, MD, PhD
marie.detrait@ghdc.be0032 60 11 20 08
CONTACTAline Gillain, MedSciences
aline.gillain@ghdc.be0032 60 11 00 89
PRINCIPAL_INVESTIGATORMarie Detrait, MD, PhD

Grand Hôpital de Charleroi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026