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Набор скоро начнётся NCT07611695

Artificial Intelligence-driven Tuberculosis Landscape Analysis & Stratification Research

Наблюдательное Pulmonary Tuberculosis Tuberculosis (TB) Tuberculosis Active

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Pulmonary Tuberculosis, Tuberculosis (TB), Tuberculosis Active. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The goal of this observational study is to establish and validate a comprehensive AI-driven clinical decision support system (AI-CDSS) in whole-chain management for pulmonary tuberculosis (TB) patients. The main question it aims to answer is: How is the predictive performance of this system in terms of multiple key links during TB diagnosis and treatment? Can real-world benefits be derived from this system? This AI framework supports clinicians in making smarter decisions, ultimately improving cure rates and ensuring that every patient receives the most effective, personalized care possible.

Подробное описание

This study establishes TB-ATLAS (Artificial Intelligence-driven Tuberculosis Landscape Analysis \& Stratification Research), a modular framework for whole-chain TB management. The objective is to develop and validate an umbrella suite of AI-driven models to optimize clinical decision-making from initial diagnosis to post-treatment follow-up.

The core hypothesis is that multimodal patient data can stratify TB phenotypes and predict critical clinical events, enabling precision medicine. Beyond the primary focus on distinguishing Easy-to-Treat (ETT) from Hard-to-Treat (HTT) categories, the system incorporates satellite modules for pre-DST drug resistance risk, treatment adherence monitoring, adverse event (AE) early warning, and risk of post-TB lung disease (PTLD).

This study employs a retrospective-prospective cohort design. By utilizing retrospective IPD from clinical trials and real-world EHRs (\>30,000 patients), the investigators apply advanced AI, including foundation models for feature representation and multi-task learning for modular development. Integration of structured clinical variables, microbiological profiles, radiomics, and host signatures ensures high-dimensional input. Model interpretability is prioritized via SHAP/LIME to ensure clinical trust. Then the performance will be evaluated using AUROC and calibration metrics. External validation will occur in a prospective cohort (n≥1,600) to assess the system's impact on predicting real-world outcomes compared to standardized care.

The expected output is the TB-ATLAS Clinical Decision Support System (AI-CDSS). By providing evidence-based guidance on regimen intensity, resistance risk, and relapse monitoring, this platform facilitates the transition from "one-size-fits-all" standardized care towards individualized precision management, significantly enhancing clinical decision-making across diverse healthcare settings.

Первичные конечные точки

  • Predictive Performance of the "Easy-to-Treat" versus "Hard-to-Treat" stratification model for pulmonary tuberculosis (PTB) [Срок оценки: from treatment initiation to 6 months post treatment]
Вторичные конечные точки (12)
  • Brier Score of the "Easy-to-treat" versus "Hard-to-treat" Model [Срок оценки: 6 months post-treatment]
  • Calibration Slope of the "Easy-to-treat" versus "Hard-to-treat" Model [Срок оценки: 6 months post-treatment]
  • Area Under the Receiver Operating Characteristic (AUROC) Curve of the Pre-Drug Susceptibility Testing (Pre-DST) Drug Resistance Predictive Model [Срок оценки: 6 months post-treatment]
  • Area Under the Precision-Recall Curve (AUPRC) of the Pre-Drug Susceptibility Testing (Pre-DST) Drug Resistance Predictive Model [Срок оценки: 6 months post-treatment]
  • F1-score of the Secondary Decision Models for Pre-Drug Susceptibility Testing (Pre-DST) Drug Resistance Prediction [Срок оценки: 6 months post-treatment]
  • Area Under the Receiver Operating Characteristic (AUROC) Curve of the Adherence Forecasting Model [Срок оценки: From treatment initiation until treatment completion, assessed up to 6 months]
  • Area Under the Precision-Recall Curve (AUPRC) of the Adherence Forecasting Model [Срок оценки: From treatment initiation until treatment completion, assessed up to 6 months]
  • F1-score of the Secondary Decision Models for Adherence Forecasting [Срок оценки: From treatment initiation until treatment completion, assessed up to 6 months]
  • Area Under the Receiver Operating Characteristic (AUROC) Curve of the Treatment Response Predictive Model [Срок оценки: 6 months post-treatment]
  • Area Under the Precision-Recall Curve (AUPRC) of the Treatment Response Predictive Model [Срок оценки: 6 months post-treatment]
  • F1-score of the Secondary Decision Models for Treatment Response Prediction [Срок оценки: 6 months post-treatment]
  • Area Under the Receiver Operating Characteristic (AUROC) Curve of the Adverse Event (AE) Predictive Model [Срок оценки: 6 months post-treatment]

Критерии участия

Inclusion Criteria for Model Development Cohort:

  • Patient with clinically diagnosed or bacteriologically confirmed pulmonary tuberculosis (TB) who received TB treatment;
  • Initiation of TB treatment on or after January 1, 2021;
  • Complete key diagnosis and treatment data available in the electronic medical record system.

Inclusion Criteria for External Validation Cohort:

  • Patient with clinically diagnosed or bacteriologically confirmed pulmonary tuberculosis (TB) who is planning to start TB treatment;
  • Voluntary participation with signed informed consent form (for adults ≥18 years); parental / guardian consent and co-signed informed consent form are required for minors aged ≤ 18 years.

Критерии исключения

  • Co-morbidity confounding: the presence of other active, life-threatening disease (e.g. late-stage malignancy, non-HIV severe immunodeficiency) for which the expected survival or priority of treatment may substantially interfere with the attribution of TB treatment outcomes;
  • Extremely poor treatment adherence: documented evidence indicating that the patient either never initiated treatment or was permanently lost to follow-up within the early treatment period (<2 weeks), precluding the collection of any valid outcome data.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 2 центра
  • Hunan Chest Hospital — Чанша
  • Huashan Hospital Affiliated to Fudan University — Шанхай

Идентификаторы

NCT: NCT07611695 · KY2025-1517

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗