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Recruiting NCT07546188

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

Observational Lymphoma, Non-Hodgkin Care Coordination

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Retrospective Group, Prospective Group.
Who it may be relevant to
Registry conditions: Lymphoma, Non-Hodgkin, Care Coordination. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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.

Overview

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

  • Other Retrospective Group
    For the retrospective group of 20 patients.
  • Other Prospective Group
    Follow-up of the patients for the prospective group

Primary outcome measures

  • ROC-AUC [Time frame: 2027]
Secondary outcome measures (1)
  • F1-score [Time frame: When the data will be avalaible, at the end of 2027]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • Grand Hôpital de Charleroi — Charleroi

Identifiers

NCT: NCT07546188 · LNH-AI-Tools

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗