臨床研究等提出・公開システム

Date of registration	Aug. 19, 2026
Last modified on	Aug. 19, 2026
Trial ID	jRCT1010260033

Scientific Title	A prospective integrated multi-omics cohort study for the comprehensive investigation of host-microbiome interactions in systemic and intractable respiratory diseases
Public Title	A prospective study collecting and analyzing clinical information and biological samples from patients with sarcoidosis, bronchiectasis, or nontuberculous mycobacterial pulmonary disease

Contact for Scientific Queries	Name	Nakakubo Sho
	Affiliation	Hokkaido University Hospital
	Address	North 14, West 5, Kitaku, Sapporo city
	Telephone	+81-117065911
	E-mail	shonakakubo@pop.med.hokudai.ac.jp
Contact for Public Queries	Name	Nakakubo Sho
	Affiliation	Hokkaido University Hospital
	Address	North 14, West 5, Kitaku, Sapporo city
	Telephone	+81-117065911
	E-mail	shonakakubo@pop.med.hokudai.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		Sept. 01, 2026
Target sample size		300
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	health services research
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who meet either category 1 or 2 under (1) Target Population, satisfy all inclusion criteria in (2), and do not meet any exclusion criteria in (3) will be eligible for the study. (1) Target Population Patients hospitalized in the Department of Respiratory Medicine at Hokkaido University Hospital between June 22, 2026, and March 31, 2031, who fall into one of the following categories: Sarcoidosis group: Patients admitted for further evaluation of suspected sarcoidosis (including confirmed and suspected cases). Bronchiectasis/NTM group: Patients diagnosed with or suspected of having bronchiectasis or nontuberculous mycobacterial (NTM) disease, admitted for further evaluation and/or treatment. (2) Inclusion Criteria Patients aged 18 years or older at the time of obtaining informed consent. Patients who, after receiving adequate explanation and fully understanding the study, provide voluntary written informed consent to participate.
	Exclusion Criteria	Patients/Individuals deemed unsuitable for participation in this study by the principal investigator.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Sarcoidosis, Bronchiecasis, Nontuberculous mycobacterial infection
Primary Outcome(s)		To investigate whether multi-omics signatures (encompassing microbiome, metabolome, and proteome profiles) demonstrate cross-organ cross-talk and correlations among specimens from different anatomical sites.

Primary Sponsor	N/A

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Certified Review Board, Hokkaido University
Address	North 14, West 5, Kitaku, Sapporo city, Hokkaido
Telephone	+81-11-706-7934
E-Mail	recjimu@huhp.hokudai.ac.jp
Approval Status	Approval
Date of approval	June. 22, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	None