UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational study to evaluate prognostic and predictive value of initial HRCT findings in elderly patients with interstitial pneumonia
Title of the study (Brief title)	Relationship between initial HRCT findings and prognosis of interstitial pneumonia in elderly
Region	Japan

Condition
Condition	Interstitial pneumonia
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the relationship between initial HRCT finding and prognosis in elderly patients with interstitial pneumonia.
Basic objectives2	Others
Basic objectives -Others	Prospective observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference of progression free survival (PFS) in each group. Definition of progression is 10% < decline of %FVC or 15% < decline of DLCO compared with initial pulmonary function test, the introduction of home oxygen therapy, more than 90days hospitalization due to irreversible worsening of respiratory status, or death.
Key secondary outcomes	Secondary outcomes are the changes of Modified Medical Research Council Dyspnea Scale, percutaneous oxygen saturation, partial pressure of oxygen in arterial blood, vital capacity, forced vital capacity, the distance and minimum SPO2 of 6 minutes walk test, KL-6/SP-D, Overall Survival.

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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Eligible patients are men and women aged 75 years or older with interstitial pneumonia in initial chest HRCT.
Key exclusion criteria	Patients who have malignant tumor, defined connective tissue disease, occupational and/or environmental exposure that resulted in interstitial pneumonia, or drug induced interstitial pneumonia are excluded from this study. Patient who have already used home oxygen therapy at first visit are also excluded.
Target sample size	40

Research contact person
Name of lead principal investigator	Kazuyoshi Imaizumi
Organization	Fujita Health University School of Medicine
Division name	Division of Respiratory Medicine and Clinical Allergy
Address	1-98 Dengakugakubo Kutsukake-cho Toyoake, Aichi Japan
TEL	0562-93-9241
Email	jeanluc@fujita-hu.ac.jp

Public contact
Name of contact person	Tomoyuki Minezawa
Organization	Fujita Health University School of Medicine
Division name	Division of Respiratory Medicine and Clinical Allergy
Address	1-98 Dengakugakubo Kutsukake-cho Toyoake, Aichi Japan
TEL	0562-93-9241
Homepage URL
Email	minezawa@fujita-hu.ac.jp

Sponsor
Institute	Division of Respiratory Medicine and Clinical Allergy,Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization	Division of Respiratory Medicine and Clinical Allergy,Fujita Health University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2014 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 07 Day
Anticipated trial start date	2014 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To assess the relationship between initial HRCT finding and prognosis in elderly patients with interstitial pneumonia.

Management information
Registered date	2014 Year 01 Month 23 Day
Last modified on	2018 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015111