Tokyo, Feb. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060591) titled 'A prospective observational study to clarify the usefulness of bronchial lavage in patients with anti-GPL-core IgA antibody-positive pulmonary nontuberculous mycobacterial disease' on Feb. 5.
Study Type:
Observational
Primary Sponsor:
Institute - Himeji Saint Mary's Hospital
Condition:
Condition - Patients scheduled for bronchoscopy for the diagnosis of NTM
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to clarify the usefulness of bronchial lavage (BL) during bronchoscopy in diagnosing pulmonary nontuberculous mycobacterial disease in patients with positive anti-GPL-core IgA antibodies (GPL core IgA antibodies: MAC antibodies 0.7 U/mL or higher).
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - (a) Patients eligible for bronchoscopy
(b) Patients undergoing elective bronchoscopy
(c) Patients with a performance status of 2 or less
(d) Patients with written consent
(e) Patients aged 20 years or older (regardless of gender)
(f) Patients with positive MAC antibodies (qualitative mycobacterial antibodies) (GPL core IgA antibody: MAC antibody 0.7 U/mL or higher)
Key exclusion criteria - (a) Patients with contraindications for bronchoscopy
(b) Patients with mental conditions that make it difficult to participate in a clinical trial
(C) Patients who are otherwise deemed inappropriate for enrollment in this study by a physician
Target Size - 50
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 01 Month 26 Day
Date of IRB - 2026 Year 01 Month 26 Day
Anticipated trial start date - 2026 Year 01 Month 26 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069305
Disclaimer: Curated by HT Syndication.
