UMIN-CTR Clinical Trial

Basic information
Public title	Association between telomere length and clinical indices in patients with idiopathic pulmonary fibrosis
Acronym	Telomere length in idiopathic pulmonary fibrosis
Scientific Title	Association between telomere length and clinical indices in patients with idiopathic pulmonary fibrosis
Scientific Title:Acronym	Telomere length in idiopathic pulmonary fibrosis
Region	Japan

Condition
Condition	Idiopathic pulmonary fibrosis (IPF)
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To investigate the natural course of the telomere length and determine whether the attrition of telomeres could be slowed by administration of antifibrotic agents in patients with idiopathic pulmonary fibrosis. Besides, we examine the relationship between telomere length and clinical indices.
Basic objectives2	Others
Basic objectives -Others	To explore whether the genetic mutation and allelic polymorphisms could associate with telomere length or clinical indices in patients with IPF.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Reduction in the telomere length attrition rate by administration of antifibrotic agent.
Key secondary outcomes

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
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Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients diagnosed with idiopathic pulmonary fibrosis based on guidelines of an official ATS/ERS/JRS/ALAT statement.
Key exclusion criteria	(A)Retrospective study; patients who experienced the onset of malignant disease within 3 years from first visit for our hospital. (B)Prospective study; (1) Patients with complication of malignant disease. But the patients who received complete resection or successful remission induction, and survived for more than 3 years without evidence of recurrence are eligible. (2) Patients who have been received more than 10mg/day of prednisolone or antifibrotic agents within 6 months. (3) Patients with acute exacerbation of IPF, respiratory infection, or pneumothorax within 4 weeks.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Tomohiro Middle name Last name Handa
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Respiratory Medicine
Zip code	606-8507
Address	54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-751-3830
Email	hanta@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Handa
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Respiratory Medicine
Zip code	606-8507
Address	54 Shogoin Kawahara-cho Sakyo-ku, Kyoto, Japan
TEL	075-751-3830
Homepage URL
Email	hanta@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Center for Genomic Medicine, Kyoto University. Department of Respiratory Medicine, Tenri Hospital. Department of Respiratory Medicine, Kobe City Medical Center General Hospital. Department of Respiratory Medicine, Kobe City Medical Center West Hospital. Department of Respiratory Medicine, Takatsuki Red Cross Hospital. Respiratory Disease Center, Tazuke Kofukai Medical Research Institute, Kitano Hospital. Department of Respiratory Medicine, National Hospital Organization Ibarakihigashi National Hospital. Department of Respiratory Medicine, Otsu Red Cross Hospital. Department of Respiratory Medicine, National Hospital Organization Himeji Medical Center. Department of Respiratory Medicine, Osaka Red Cross Hospital. Department of Respiratory Medicine, Kyoto City Hospital. Respiratory Disease Center, Rakuwakai Otowa Hospital. Department of Respiratory Medicine, Ohara HealthCare Foundation Kurashiki Central Hospital.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committe, Kyoto University Hospital and Kyoto University Graduate School and Faculty of Medicine
Address	Konoe-cho Sakyo-ku, Kyoto, Japan
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.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	京都大学医学部附属病院（京都府）、公益財団法人天理よろづ相談所病院（奈良県）、神戸市立医療センター中央市民病院（兵庫県）、神戸市立医療センター西市民病院（兵庫県）、高槻赤十字病院（大阪府）、公益財団法人田附興風会医学研究所北野病院（大阪府）、独立行政法人国立病院機構茨城東病院（茨城県）、大津赤十字病院（滋賀県）、独立行政法人国立病院機構 姫路医療センター（兵庫県）、大阪赤十字病院（大阪府）、京都市立病院（京都府）、洛和会音羽病院（京都府）、公益財団法人大原記念倉敷中央医療機構 倉敷中央病院（岡山県）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 07 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	2016 Year 08 Month 20 Day
Date of IRB	2016 Year 11 Month 24 Day
Anticipated trial start date	2016 Year 11 Month 24 Day
Last follow-up date	2021 Year 05 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is composed of retrospective and prospective study; (A) Retrospective study, for example, is time-series analysis or descriptive epidemiology.(B) Prospective study is cohort that conducts a longitudinal assessment of patients with IPF.

Management information
Registered date	2016 Year 10 Month 04 Day
Last modified on	2019 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026900