UMIN-CTR Clinical Trial

Basic information
Public title	Detection of novel biomarkers in patients with interstitial pneumonia or acute exacerbation of interstitial pneumonia.
Acronym	Detection of novel biomarkers in patients with interstitial pneumonia or acute exacerbation of interstitial pneumonia.
Scientific Title	Detection of novel biomarkers in patients with interstitial pneumonia or acute exacerbation of interstitial pneumonia.
Scientific Title:Acronym	Detection of novel biomarkers in patients with interstitial pneumonia or acute exacerbation of interstitial pneumonia.
Region	Japan

Condition
Condition	Patients with interstitial pneumonias or acute exacerbation of interstitial pneumonias
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate novel biomarkers for the diagnostic and prognostic significance in patients with interstitial pneumonias or acute exacerbation of interstitial pneumonias.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Diagnostic capacity, percent predicted forced vital capacity (%FVC) and diffusion lung capacity for carbon monoxide (%DLCO), the partial pressure of arterial oxygen (PaO2) at rest and minimum partial oxygen saturation during the 6-min walk test (6MWT), serum KL-6/SP-D, HRCT findings, findings on lung specimens, response to treatments

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients, who were diagnosed as interstitial pneumonias (IPs) or acute exacerbation of interstitial pneumonias from 1980, and whose serum were available, were included. IPs were diagnosed based on the presence of chest fine crackles, high-resolution computed tomography findings, and preexisting biomarkers. The diagnosis of acute exacerbation of IPs were based on diagnostic criteria for acute exacerbation of idiopathic pulmonary fibrosis (Collard H et al. AJRCCM 2016).
Key exclusion criteria	Patients with severe heart failure or excessive fluid overload were excluded.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Takafumi Middle name Last name Suda
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Zip code	431-3192
Address	1-20-1 Handayama, Higashiku, Hamamatsu
TEL	+81-53-435-2263
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	1st name Noriyuki Middle name Last name Enomoto
Organization	Hamamatsu University School of Medicine
Division name	Health administration center
Zip code	431-3192
Address	1-20-1 Handayama, Higashiku, Hamamatsu
TEL	+81-53-435-2263
Homepage URL
Email	norieno@hama-med.ac.p

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Higashiku, Hamamatsu
Tel	+81-53-435-2263
Email	+81-53-435-2263

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2021 Year 09 Month 08 Day
Date of IRB	2021 Year 08 Month 31 Day
Anticipated trial start date	2021 Year 09 Month 08 Day
Last follow-up date	2023 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2021 Year 07 Month 11 Day
Last modified on	2022 Year 10 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051199