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临床试验/NCT07546188
NCT07546188招募中不适用

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.

Grand Hôpital de Charleroi1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2026年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
210
试验地点
1
主要终点
ROC-AUC

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • All other patients who did not meet the eligibility criteria

研究组 & 干预措施

Retrospective cohort

A retrospective cohort from 2019 to 2024 comprising 350 lymphoma patients who were monitored on an empirical basis.

干预措施: Retrospective Group (Other)

Prospective cohort

A prospective cohort study involving up to 210 consecutive patients, starting in November 2025, with the aim of developing a decision-support tool using machine learning.

干预措施: Prospective Group (Other)

结局指标

主要结局

ROC-AUC

时间窗: 2027

Description: 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

次要结局

  • F1-score(When the data will be avalaible, at the end of 2027)

研究者

发起方
Grand Hôpital de Charleroi
申办方类型
Other
责任方
Sponsor

研究点 (1)

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