UMIN-CTR Clinical Trial

Basic information
Public title	The role of proteoglycan and glycosaminoglycan in pulmonary diseases.
Acronym	The role of proteoglycan and glycosaminoglycan in pulmonary diseases.
Scientific Title	The role of proteoglycan and glycosaminoglycan in pulmonary diseases.
Scientific Title:Acronym	The role of proteoglycan and glycosaminoglycan in pulmonary diseases.
Region	Japan

Condition
Condition	Pulmonary diseases
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the role of proteoglycan and glycosaminoglycan in pulmonary diseases.
Basic objectives2	Others
Basic objectives -Others	To evaluate the usefulness of proteoglycan and glycosaminoglycan concentrations in serum and bronchoalveolar lavage (BAL) fluid as a biomarker.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The relationship between proteoglycan and glycosaminoglycan in serum and BAL fluid and severity and prognosis of pulmonary diseases.
Key secondary outcomes	The relationship between proteoglycan and glycosaminoglycan in serum and BAL fluid and clinical parameters of pulmonary diseases.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who were diagnosed as having pulmonary diseases such as interstitial pneumonia, sarcoidosis, acute pneumonia, chronic obstructive pulmonary disease (COPD), eosinophilic pneumonia and lung cancer in the Department of Pulmonary Medicine, Fukushima Medical University Hospital and normal volunteers. They received serum and/or BAL fluid sampling, and agreed to be involved in this clinical study.
Key exclusion criteria	Patients with pulmonary diseases without serum and/or BAL fluid sampling.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Mitsuru Middle name Last name Munakata
Organization	School of Medicine, Fukushima Medical University
Division name	Department of Pulmonary Medicine
Zip code	9601295
Address	1 Hikarigaoka, Fukushima City, Fukushima, JAPAN
TEL	024-547-1360
Email	pulmo@fmu.ac.jp

Public contact
Name of contact person	1st name Yoshinori Middle name Last name Tanino
Organization	School of Medicine, Fukushima Medical University
Division name	Department of Pulmonary Medicine
Zip code	9601295
Address	1 Hikarigaoka, Fukushima City, Fukushima, JAPAN
TEL	024-547-1360
Homepage URL	http://www.fmu.ac.jp
Email	pulmo@fmu.ac.jp

Sponsor
Institute	Department of Pulmonary Medicine, School of Medicine, Fukushima Medical University
Institute
Department

Funding Source
Organization	Department of Pulmonary Medicine, School of Medicine, Fukushima Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Fukushima Medical University
Address	1 Hikarigaoka, Fukushima 9601295, JAPAN
Tel	0245471360
Email	pulmo@fmu.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	福島県立医科大学病院（福島県）

Other administrative information
Date of disclosure of the study information	2011 Year 04 Month 21 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	Completed
Date of protocol fixation	2010 Year 07 Month 09 Day
Date of IRB	2010 Year 09 Month 14 Day
Anticipated trial start date	2010 Year 07 Month 01 Day
Last follow-up date	2018 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The clinical significance of proteoglycan and glycosaminoglycan has not been clarified. Therefore, we will perfoem the prospective observational study to evaluate the relationship between proteoglycan and glycosaminoglycan in serum and/or BAL fluid from patients with pulmonary diseases and clinical parameters and prognosis. For the subjects who had been already underwent the serum and/or BAL fluid sampling and agreed to be involved in this clinical study will be included and analyzed restrospectively.

Management information
Registered date	2011 Year 04 Month 21 Day
Last modified on	2020 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006493