Clinical Characteristics and Immune Escape Mechanism of Nontuberculous Mycobacterial Lung Disease in South China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,500
- 主要终点
- Clinical Phenotype Distribution
研究概览
简要总结
Nontuberculous Mycobacterial lung disease (NTM-LD) is a significant infectious challenge. The precise causes remain unclear, diagnosis can be complex, treatment outcomes are often unsatisfactory, and the disease can severely affect a patient's quality of life. Environmental factors, such as the warm and humid climate in South China, may contribute to unique characteristics of NTM in this region, but systematic research is currently lacking.
This study aims to improve the understanding of NTM-LD in South China. It consists of two complementary parts:
- The first part is a retrospective review of medical records from approximately 1,500 NTM patients across multiple hospitals in South China. This analysis seeks to identify common patterns in symptoms, diagnostic findings, and treatment responses within this population.
- The second part is a prospective study involving about 106 current NTM-LD patients. Blood and lung fluid samples will be collected to analyze, using advanced laboratory techniques, how the patient's immune system responds to the infection. This investigation aims to uncover clues about why some cases are difficult to treat.
The overall goal of this research is to generate evidence that can aid healthcare providers in South China in diagnosing and managing NTM-LD more effectively. Please note that this is an observational study; no new drugs or experimental treatments are being tested.
详细描述
- Background and Rationale NTM-LD presents significant clinical challenges due to its unclear pathogenesis, diagnostic complexity, suboptimal treatment outcomes, and poor prognosis. The unique climatic (hot, humid) and demographic factors in South China suggest potential regional variations in NTM epidemiology and clinical presentation. However, a systematic investigation into its clinical characteristics and underlying mechanisms in this region is lacking, impeding the development of localized precision medicine strategies.
- Study Objectives Primary Objective: To systematically characterize the epidemiological patterns, clinical phenotypes, and prognostic determinants of NTM-LD in the South China population.
Secondary Objectives:
To analyze the distribution of NTM species and their correlation with disease severity and radiological findings.
To investigate host immune microenvironment alterations post-NTM infection, focusing on inflammatory responses and immune cell functional states.
To explore molecular mechanisms associated with treatment refractoriness in NTM disease. 3. Study Design
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Both Cohorts):
- •Patients diagnosed with nontuberculous mycobacterial according to standard guidelines.
- •Aged 18 years or older.
- •Available medical records covering the period from 2015 to 2025 (for the retrospective cohort).
- •2. (Prospective Sub-cohort Additional):
- •Willing and able to provide written informed consent for biospecimen collection.
- •Clinically stable and suitable for undergoing research bronchoalveolar lavage (BAL) procedure, as judged by the investigator.
排除标准
- •(Both Cohorts):
- •Active tuberculosis or other dominant pulmonary infections.
- •Incomplete medical records that preclude adequate data extraction (for retrospective analysis).
- •2. (Prospective Sub-cohort Additional):
- •Contraindications to bronchoscopy or BAL procedure.
- •Pregnancy or lactation.
- •Any condition that, in the opinion of the investigator, would compromise patient safety or data integrity.
研究组 & 干预措施
Retrospective NTM Cohort
This cohort consists of approximately 1,500 patients diagnosed with nontuberculous mycobacterial (NTM) across multiple hospitals in South China. Data, including demographics, clinical symptoms, imaging findings, microbiology results, and treatment outcomes, will be extracted retrospectively from electronic medical records for the period from January 2015 to May 2025.
干预措施: Prospective Biospecimen Sub-cohort (Other)
结局指标
主要结局
Clinical Phenotype Distribution
时间窗: At time of diagnosis (assessed retrospectively from medical records between January 2015 and May 2025)
Proportion of patients with different clinical-radiological phenotypes of NTM-LD (nodular-bronchiectatic, fibrocavitary, hypersensitivity-like, and mixed patterns) based on chest CT imaging and clinical presentation.
Treatment Response Categories
时间窗: 12 months post-diagnosis (assessed retrospectively from medical records between January 2015 and May 2025)
Distribution of treatment outcomes including: (1) microbiological conversion (negative cultures for ≥12 months), (2) treatment failure (persistent positive cultures despite appropriate therapy), (3) treatment intolerance requiring discontinuation, and (4) spontaneous improvement without treatment.
次要结局
- Spectrum of NTM Species(Species distribution will be assessed at baseline, defined as the date of the first positive NTM culture from a respiratory specimen. Retrospective data collection will cover the period from January 2015 to May 2025.)
- Clinical Prognostic Factors(Assessed at baseline (within 7 days of enrollment).)
- Immunological Prognostic Factors(Serum sample collected at baseline (within 7 days of enrollment) for antibody testing.)