UMIN-CTR Clinical Trial

Basic information
Public title	Multiinstitutional prospective study on idiopathic interstitial pneumonias with features similar to collagen vascular diseases
Acronym	IIPs with features similar to CVD
Scientific Title	Multiinstitutional prospective study on idiopathic interstitial pneumonias with features similar to collagen vascular diseases
Scientific Title:Acronym	IIPs with features similar to CVD
Region	Japan

Condition
Condition	Idiopathic interstitial pneumonias
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical course and prognosis in idiopathic interstitial pneumonias with features similar to collagen vascular diseases
Basic objectives2	Others
Basic objectives -Others	To evaluate the incidence of idiopathic interstitial pneumonias with features similar to collagen vascular diseases
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Overall survival rate
Key secondary outcomes	Change in Forced Vital Capacity, Change of lung opacities on High Resolution Computed Tomography

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 with idiopathic interstitial pneumonias
Key exclusion criteria	Patients who meet the criteria for any collagen vascular diseases
Target sample size	350

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, Japan
TEL	81534352263
Email	norieno@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	Second Division, Department of Internal Medicine
Zip code	431-3192
Address	1-20-1 Handayama, Higashiku, Hamamatsu, Japan
TEL	81534352263
Homepage URL
Email	norieno@hama-med.ac.jp

Sponsor
Institute	Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Health, Labor, and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Hamamatsu University School of Medcine
Address	1-20-1 Handayama, Higashiku, Hamamatsu, Japan
Tel	053-435-2263
Email	norieno@hama-med.ac.jp

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	2013 Year 04 Month 01 Day

Related information
URL releasing protocol	https://www.hama-med.ac.jp/uni-e/
Publication of results	Published

Result
URL related to results and publications	https://thorax.bmj.com/content/77/2/143.long
Number of participants that the trial has enrolled	376
Results	In this multicenter cohort study, 376 patients with IIP prospectively enrolled, and 70 patients (18.6%) met the IPAF criteria. During a median observation period of 35 months, patients with IPAF more frequently developed systemic autoimmune diseases and had less frequent acute exacerbation of IIPs than patients with non-IPAF. IPAF diagnosis was significantly associated with better survival and was an independent positive prognostic factor in total and patients with non-IPF.
Results date posted	2022 Year 10 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients with idiopathic interstitial pneumonia
Participant flow	Multicenter prospective cohort study
Adverse events	none
Outcome measures	Survival in patients with IPAF
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 03 Month 31 Day
Date of IRB	2013 Year 03 Month 29 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Incidence, response rate to treatments, and prognosis will be observed prospectively in patients with idiopathic interstitial pneumonias with features similar to collagen vascular diseases. Patients with idiopathic interstitial pneumonias will be enrolled consecutively.

Management information
Registered date	2013 Year 03 Month 13 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=R000011953