Tokyo, April 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061160) titled 'Bronchoscopy plus post-bronchoscopy sputum and gastric fluid for improved NTM diagnosis' on April 15.

Study Type: Observational

Primary Sponsor: Institute - Japanese Red Cross Kyoto Daiichi Hospital

Condition: Condition - nontuberculous mycobacterial pulmonary disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to evaluate, in a multicenter prospective observational setting, the incremental diagnostic yield obtained by adding gastric aspirate culture and post-bronchoscopy sputum (PBS) to bronchoscopy in patients with suspected pulmonary nontuberculous mycobacterial disease who undergo bronchoscopic examination.

Furthermore, this study aims to assess the usefulness of a diagnostic approach combining these specimens and to clarify the optimal bronchoscopy-based diagnostic protocol for NTM-PD. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients suspected of having pulmonary nontuberculous mycobacterial disease (NTM-PD) based on clinical findings, including imaging findings such as nodular opacities, branching opacities, diffuse homogeneous opacities, cavitary opacities, or bronchial/bronchiolar dilatation. 2. Patients who are scheduled to undergo bronchoscopy as part of routine clinical care for the diagnosis of NTM-PD, with planned collection of post-bronchoscopy sputum (PBS) and gastric aspirate for culture. 3. Patients aged 20 years or older at the time of enrollment. 4. Patients who are unable to submit sputum for culture before bronchoscopy, or who have not had the same mycobacterial species identified as positive on two or more occasions. 5. Patients from whom written informed consent to participate in this study has been obtained. Key exclusion criteria - 1. Patients who already meet the diagnostic criteria for pulmonary nontuberculous mycobacterial disease (NTM-PD) before bronchoscopy, or who have a history of treatment for NTM-PD. 2. Patients in whom any of the following specimens were not obtained: bronchoscopic specimens, gastric aspirate for culture, or post-bronchoscopy sputum (PBS). 3. Patients in whom diseases other than NTM-PD, such as pulmonary tuberculosis or lung cancer, are strongly suspected based on clinical findings including imaging findings. 4. Patients who are otherwise considered inappropriate for participation in this study by the principal investigator or the attending physician. Target Size - 150

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 03 Month 18 Day Date of IRB - 2026 Year 03 Month 18 Day Anticipated trial start date - 2026 Year 03 Month 19 Day Last follow-up date - 2028 Year 03 Month 19 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069989

Disclaimer: Curated by HT Syndication.