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Clinical diagnostic perfomance of non-tuberculous Mycobacterium specific antigen peptide chip

Clinical diagnostic perfomance of MHC presenting antigen peptide chip based on human lung tissue of patient with non-tuberculosis mycobacterium pulmonary disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000032466
Enrollment
Unknown
Registered
2020-04-29
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-tuberculosis mycobacterium pulmonary disease

Interventions

Gold Standard:Meet one of the following criteria: 1.The culture of sputum NTM was positive twice and the same NTM strain was detected by molecular tests
2.The culture of NTM in BALF was positive for once + the culture of sputum NTM was positive once,and the same NTM strain was detected by molecular tests.
Index test:non-tuberculosis&#32
MHC&#32
presenting&#32

Sponsors

Shanghai Pulmonary Hospital affiliated to Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The suspected cases of NTM with unclear diagnosis were detected by radiology; 2. Patients aged 16-75; 3. Gender is not limited; 4. Those patients who can understand the patients signing the informed consent.

Exclusion criteria

Exclusion criteria: 1. HIV positive patients; 2. Pregnancy or patients with liver, kidney, metabolism, autoimmune diseases, neurological, mental or endocrine diseases, blood system diseases, malignant tumors, long-term use of immunosuppressant / hormone, etc; 3. According to the judgment of the investigator, there are any diseases that are not suitable for the study or may prevent the patients from participating in the whole study; 4. Patients participating in other clinical studies at the same time; 5. Patients with a history of poor compliance in other clinical trials.

Design outcomes

Primary

MeasureTime frame
host response to NTM specific antigen peptides;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactQin Sun

Shanghai Pulmonary Hospital affiliated to Tongji University

sunqinbonjour@163.com+86 13774289331

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026