UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058592 |
|---|---|
| Receipt number | R000066987 |
| Scientific Title | Ishinomaki Interstitial Lung Diseases Cohort Study |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/09/11 11:37:45 |
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Basic information
Public title
Ishinomaki Interstitial Lung Diseases Cohort Study
Acronym
Ishinomaki ILD Study
Scientific Title
Ishinomaki Interstitial Lung Diseases Cohort Study
Scientific Title:Acronym
Ishinomaki ILD Study
Region
| Japan |
Condition
Condition
Interstitial lung diseases
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical characteristics and outcomes of Japanese patients with interstitial lung diseases.
Basic objectives2
Others
Basic objectives -Others
Observational study without intervention
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Prognosis
Key secondary outcomes
Clinical features, symptoms and physical findings, complications and comorbidities, blood and biochemical tests, chest imaging, respiratory function, and presence of acute exacerbations
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Aged 18 years or older at the time of enrollment.
2) Diagnosis of interstitial lung diseases confirmed by An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline 2022 and the corresponding guidelines for each diseases.
3) Ability to understand the study procedures and provide written informed consent.
Key exclusion criteria
1) Patients who are not scheduled to undergo any of the tests in this study; 2) Patients who have undergone a lobectomy or greater by the time of enrollment; or 3) Patients who are deemed inappropriate by the principal investigator or subinvestigators for any other reason.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Seiichi |
| Middle name | |
| Last name | Kobayashi |
Organization
Japanese Red Cross Ishinomaki Hospital
Division name
Department of Respiratory Medicine
Zip code
986-8522
Address
71 Nishimichishita, Hebita, Ishinomaki, Miyagi, Japan
TEL
0225-21-7220
skoba-thk@umin.ac.jp
Public contact
Name of contact person
| 1st name | Seiichi |
| Middle name | |
| Last name | Kobayashi |
Organization
Japanese Red Cross Ishinomaki Hospital
Division name
Department of Respiratory Medicine
Zip code
986-8522
Address
71 Nishimichishita, Hebita, Ishinomaki, Miyagi, Japan
TEL
0225-21-7220
Homepage URL
skoba-thk@umin.ac.jp
Sponsor or person
Institute
Japanese Red Cross Ishinomaki Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Ishinomaki Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
IPPIN (Interstitial Pneumonia Protected by Ishinomaki Network)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Japanese Red Cross Ishinomaki Hospital
Address
71 Nishimichishita, Hebita, Ishinomaki, Miyagi, Japan
Tel
0225-21-7220
chiken@ishinomaki.jrc.or.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
石巻赤十字病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 01 | 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
| 2025 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective, observational cohort study designed to evaluate clinical characteristics and outcomes in Japanese patients with ILDs including interstitial pneumonia. Eligible participants will be enrolled at the Japanese Red Cross Ishinomaki Hospital and followed for up to 3-years. Data will be collected at baseline and at scheduled follow-up visits. This study is a local registry-based observational study, and no intervention will be administered as part of the study. All treatments and clinical decisions will be made at the discretion of the attending physicians in accordance with standard clinical practice.
Management information
Registered date
| 2025 | Year | 07 | Month | 24 | Day |
Last modified on
| 2025 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066987
