Nontuberculous Mycobacterial Lung DiseaseNTM-LDNCT07377864
Clinical Characteristics and Immune Escape Mechanism of Nontuberculous Mycobacterial Lung Disease in South China
An observational study of Nontuberculous Mycobacterial Lung Disease and Mycobacterium Avium Complex (MAC), run by Eighth Affiliated Hospital, Sun Yat-sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nontuberculous Mycobacterial Lung Disease, Mycobacterium Avium Complex (MAC)
- What is being tested?
- Prospective Biospecimen Sub-cohort
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mianluan Dr Pan, Dr contact
About this study
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:
Read more
- 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.
Read the detailed description
- 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.
- Study Design This is a hybrid observational study comprising two distinct parts:
- Part 1: A multicenter, retrospective, non-interventional survey study.
- Part 2: A prospective observational study involving biospecimen collection and laboratory analysis.
- Study Populations and Sample Size
- Part 1: Approximately 1,500 patients diagnosed with NTM lung disease per standard guidelines between January 2015 and May 2025 across multiple collaborating centers in South China.
- Part 2: A subset of 106 consecutively enrolled, confirmed NTM patients from the collaborating network for prospective biospecimen collection.
- Methods and Procedures
- Part 1 (Retrospective Survey): Data on demographics, clinical symptoms, imaging features (chest CT), microbiology, treatment regimens, and outcomes will be extracted from electronic health records. Statistical analyses will include descriptive summaries, correlation studies, and multivariable regression modeling to identify prognostic factors.
- Part 2 (Prospective Study): Peripheral blood and bronchoalveolar lavage fluid (BALF) will be collected. Analyses will include: Molecular Biology: Real-time quantitative PCR for cytokine expression profiling; Western blot for protein-level assessment. Single-Cell Sequencing: To delineate immune cell composition, transcriptional states, and cell-cell interaction networks within the pulmonary immune microenvironment.
- Statistical Analysis For Part 1, appropriate statistical tests (e.g., Chi-square, t-test, ANOVA, Kaplan-Meier survival analysis, Cox regression) will be applied based on data types and distribution. For Part 2, bioinformatics pipelines specific for single-cell RNA sequencing data will be employed for clustering, differential expression, and pathway analysis. A p-value <0.05 will be considered statistically significant.
- Ethics and Data Management The study protocol will be submitted for approval to The Eighth Affiliated Hospital of Sun Yat-Sen University Ethics Committee of all participating centers prior to initiation. Patient informed consent will be obtained for the prospective Part 2. All data will be de-identified, coded, and stored on secure, password-protected servers in compliance with data protection regulations.
- Significance This study is expected to generate a comprehensive clinical profile of NTM lung disease in South China and provide novel insights into its pathogenesis at the immune-microenvironment level. The findings may contribute to more accurate diagnostic criteria, prognostic models, and inform the future development of targeted therapeutic strategies for this refractory infection.
- Being tested
- Prospective Biospecimen Sub-cohort
- Keywords
- Nontuberculous Mycobacterial, South China, Immune Escape, Outcome
- Medical subject headings
- Mycobacterium avium-intracellulare Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective Biospecimen Sub-cohortOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Prospective Biospecimen Sub-cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months post-diagnosis (assessed retrospectively from medical records between January 2015 and May 2025)
Secondary outcomes (3)
Spectrum of NTM Species
The spectrum and relative frequency of nontuberculous mycobacteria (NTM) species isolated from respiratory specimens (including sputum and bronchoalveolar lavage fluid) will be determined through retrospective analysis of positive culture and species identification results from the hospital's microbiology laboratory database. All patients with confirmed NTM pulmonary disease will be included in this analysis.
Measured: 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
Specific clinical variables assessed for their association with treatment outcome. These include: presence of cavitation on baseline chest CT, body mass index (BMI) < 18.5 kg/m² at diagnosis, CCI, NLR, NMLR, and a history of previous NTM treatment failure.
Measured: Assessed at baseline (within 7 days of enrollment).
Immunological Prognostic Factors
Specific immunological variables assessed for their association with treatment outcome. This primarily refers to the presence and titer of neutralizing anti-interferon-gamma autoantibodies (nIFN-γ-autoAbs) in serum.
Measured: Serum sample collected at baseline (within 7 days of enrollment) for antibody testing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nontuberculous Mycobacterial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Eighth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianquan Zhang, Study chair, The Eighth Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377864
- Sponsor's protocol ID
- 2025-184-01
- Acronym
- NTM-LD
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: What data in particular will be shared? • De-identified individual participant data that underlie the results reported in the primary publication (including baseline characteristics, primary and secondary outcome measures). What other documents will be available? • Study protocol, statistical analysis plan, and informed consent form (if applicable). When will data be available (start and end dates)? • Beginning 1year after the publication of the primary results and ending 5 years thereafter. With whom? • Researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. For what types of analyses? • For individual participant data meta-analysis or other secondary analyses approved by the proposal assessment committee. By what mechanism will data be made available? • Proposals should be directed to \[principal investigator's email address, jqzhang2002@126.com\]. To gain access, requestors will need to sign a data access agreement. Data will be shared v
Publications
Pan M, Wei Y, Luo C, Lin H, Lu W, Lin Y, Mai Z, Deng J, Huang Y, Yu H, Huang J, Zhang J. Tracheobronchial invasion by nontuberculous mycobacteria: a rare but overlooked clinical manifestation-a multicenter retrospective analysis. Front Cell Infect Microbiol. 2026 Jul 13;16:1872833. doi: 10.3389/fcimb.2026.1872833. eCollection 2026.
PubMed 42516434
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Immune Escape Mechanism of Nontuberculous Mycobacterial Lung Disease in South China
- ClinicalTrials.gov ID
- NCT07377864
- Acronym / sponsor ID
- NTM-LD / 2025-184-01
- Keywords
- Nontuberculous Mycobacterial, South China, Immune Escape, Outcome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Eighth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- Study Design This is a hybrid observational study comprising two distinct parts:
- Part 1: A multicenter, retrospective, non-interventional survey study.
- Part 2: A prospective observational study involving biospecimen collection and laboratory analysis.
- Study Populations and Sample Size
- Part 1: Approximately 1,500 patients diagnosed with NTM lung disease per standard guidelines between January 2015 and May 2025 across multiple collaborating centers in South China.
- Part 2: A subset of 106 consecutively enrolled, confirmed NTM patients from the collaborating network for prospective biospecimen collection.
- Methods and Procedures
- Part 1 (Retrospective Survey): Data on demographics, clinical symptoms, imaging features (chest CT), microbiology, treatment regimens, and outcomes will be extracted from electronic health records. Statistical analyses will include descriptive summaries, correlation studies, and multivariable regression modeling to identify prognostic factors.
- Part 2 (Prospective Study): Peripheral blood and bronchoalveolar lavage fluid (BALF) will be collected. Analyses will include: Molecular Biology: Real-time quantitative PCR for cytokine expression profiling; Western blot for protein-level assessment. Single-Cell Sequencing: To delineate immune cell composition, transcriptional states, and cell-cell interaction networks within the pulmonary immune microenvironment.
- Statistical Analysis For Part 1, appropriate statistical tests (e.g., Chi-square, t-test, ANOVA, Kaplan-Meier survival analysis, Cox regression) will be applied based on data types and distribution. For Part 2, bioinformatics pipelines specific for single-cell RNA sequencing data will be employed for clustering, differential expression, and pathway analysis. A p-value <0.05 will be considered statistically significant.
- Ethics and Data Management The study protocol will be submitted for approval to The Eighth Affiliated Hospital of Sun Yat-Sen University Ethics Committee of all participating centers prior to initiation. Patient informed consent will be obtained for the prospective Part 2. All data will be de-identified, coded, and stored on secure, password-protected servers in compliance with data protection regulations.
- Significance This study is expected to generate a comprehensive clinical profile of NTM lung disease in South China and provide novel insights into its pathogenesis at the immune-microenvironment level. The findings may contribute to more accurate diagnostic criteria, prognostic models, and inform the future development of targeted therapeutic strategies for this refractory infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective NTM Cohort | – | Other: Prospective Biospecimen Sub-cohortThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
- 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.
Key exclusion criteria (6 listed)
- Active tuberculosis or other dominant pulmonary infections.
- Incomplete medical records that preclude adequate data extraction (for retrospective analysis).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective Biospecimen Sub-cohortObservational | Other | Retrospective NTM Cohort |
Primary outcome
Clinical Phenotype Distribution
Time frame: 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
Time frame: 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.
3 secondary outcomes
Spectrum of NTM Species
Time frame: 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
Time frame: Assessed at baseline (within 7 days of enrollment).
Immunological Prognostic Factors
Time frame: Serum sample collected at baseline (within 7 days of enrollment) for antibody testing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 42516434Pan M, Wei Y, Luo C, Lin H, Lu W, Lin Y, Mai Z, Deng J, Huang Y, Yu H, Huang J, Zhang J. Tracheobronchial invasion by nontuberculous mycobacteria: a rare but overlooked clinical manifestation-a multicenter retrospective analysis. Front Cell Infect Microbiol. 2026 Jul 13;16:1872833. doi: 10.3389/fcimb.2026.1872833. eCollection 2026.
- Individual participant dataSharing planned: Yes. What data in particular will be shared? • De-identified individual participant data that underlie the results reported in the primary publication (including baseline characteristics, primary and secondary outcome measures). What other documents will be available? • Study protocol, statistical analysis plan, and informed consent form (if applicable). When will data be available (start and end dates)? • Beginning 1year after the publication of the primary results and ending 5 years thereafter. With whom? • Researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. For what types of analyses? • For individual participant data meta-analysis or other secondary analyses approved by the proposal assessment committee. By what mechanism will data be made available? • Proposals should be directed to [principal investigator's email address, jqzhang2002@126.com]. To gain access, requestors will need to sign a data access agreement. Data will be shared v
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mianluan Dr Pan, Dr contact
Jianquan Zhang study chair
The Eighth Affiliated Hospital of Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Nontuberculous Mycobacterial Lung Disease and Mycobacterium Avium Complex (MAC), run by Eighth Affiliated Hospital, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianquan Zhang, Dr (0755-83982222, jqzhang2002@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Phenotype Distribution (time frame: At time of diagnosis (assessed retrospectively from medical records between January 2015 and May 2025)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07377864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.