Clinical Characteristics and Immune Escape Mechanism of Nontuberculous Mycobacterial Lung Disease in South China

NCT07377864 | Not Yet Recruiting

• 1 other identifier: 2025-184-01
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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:

1. 1.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.
2. 2.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.

Conditions

Nontuberculous Mycobacterial Lung Disease; Mycobacterium Avium Complex (MAC)

Keywords

Nontuberculous Mycobacterial; South China; Immune Escape; Outcome

Outcome Measures

Primary Outcomes (2)

• Clinical Phenotype Distribution

  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.

  At time of diagnosis (assessed retrospectively from medical records between January 2015 and May 2025)

• Treatment Response Categories

  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.

  12 months post-diagnosis (assessed retrospectively from medical records between January 2015 and May 2025)

Secondary Outcomes (3)

• 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.

Study Arms (1)

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.

Other: Prospective Biospecimen Sub-cohort

Interventions

Prospective Biospecimen Sub-cohort OTHER

Observational

Retrospective NTM Cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study population comprises patients diagnosed with nontuberculous mycobacterial infection in South China. It includes two nested cohorts: (1) a large multicenter retrospective cohort of approximately 1,500 patients identified from hospital records between 2015 and 2025, from whom clinical and epidemiological data will be extracted; and (2) a prospective sub-cohort of about 106 patients consecutively enrolled from the aforementioned group, who will provide additional biospecimens (peripheral blood and bronchoalveolar lavage fluid) for mechanistic laboratory investigations.

You may qualify if:

• 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).
• \. (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.

You may not qualify if:

• Active tuberculosis or other dominant pulmonary infections.
• Incomplete medical records that preclude adequate data extraction (for retrospective analysis).
• \. (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.

Sponsors & Collaborators

• Eighth Affiliated Hospital, Sun Yat-sen University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood mononuclear cells (PBMCs) and bronchoalveolar lavage fluid (BALF) cells.

MeSH Terms

Conditions

Mycobacterium avium-intracellulare Infection

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Jianquan Zhang

  The Eighth Affiliated Hospital of Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Jianquan Zhang, Dr

CONTACT

0755-83982222; jqzhang2002@126.com

Mianluan Dr Pan, Dr

CONTACT

2693754132@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 30, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 30, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 1year after the publication of the primary results and ending 5 years thereafter.
• Access Criteria: 1. Access will be granted to external researchers (including individuals affiliated with academic institutions, healthcare organizations, or non-commercial research entities) who provide a methodologically sound research proposal that has received ethical approval (if applicable) from an institutional review board. The proposal must align with the original study's ethical framework and informed consent provisions. Proposals for commercial purposes will not be considered. 2. Requestors may access the following de-identified datasets and documents: 1\. Individual Participant Data: Key de-identified variables including demographics (age, gender), clinical characteristics (symptoms, imaging phenotypes, NTM species), laboratory results, and primary/secondary outcome measures. 2\. Supporting Documents: The final approved study protocol, the statistical analysis plan, the informed consent form template, and the data dictionary defining all variables.