UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059730 |
|---|---|
| Receipt number | R000068308 |
| Scientific Title | Surrogate Endpoints for Overall Survival in Idiopathic Pulmonary Fibrosis Trials with Medical Interventions |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/11/10 21:33:53 |
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Basic information
Public title
Surrogate Endpoints for Overall Survival in Idiopathic Pulmonary Fibrosis Trials with Medical Interventions
Acronym
Surrogate Endpoints for Overall Survival in Idiopathic Pulmonary Fibrosis Trials with Medical Interventions
Scientific Title
Surrogate Endpoints for Overall Survival in Idiopathic Pulmonary Fibrosis Trials with Medical Interventions
Scientific Title:Acronym
Surrogate Endpoints for Overall Survival in Idiopathic Pulmonary Fibrosis Trials with Medical Interventions
Region
| Japan |
Condition
Condition
idiopathic pulmonary fibrosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this systematic review is to evaluate the validity of surrogate endpoints in idiopathic pulmonary fibrosis trials by determining which of two endpoint categories better predicts overall survival: (i) exacerbation based endpoints (time to first exacerbation or exacerbation free survival) and (ii) composite survival endpoints (combining death with major clinical events such as hospitalization, physiologic decline, acute exacerbation, or lung transplantation). Specifically, we will assess how the hazard ratios for these endpoints (HR_ex and HR_comp) correlate with the hazard ratio for all cause mortality (HR_OS).
Basic objectives2
Others
Basic objectives -Others
To validate surrogate endpoints in IPF trials. We will quantify how HR_ex and HR_comp correlate with HR_OS using the weighted Pearson correlation coefficient, and identify which endpoint category better predicts overall survival.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The weighted Pearson's correlation coefficient (r) between the hazard ratios for surrogate endpoints - exacerbation-based (HR_ex) and composite survival endpoints (HR_comp) - and the hazard ratio for overall survival (HR_OS).
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Population: patients with idiopathic pulmonary fibrosis (IPF).
Diagnostic certainty: possible, probable, or definite IPF will be treated collectively as IPF if permitted by the original study design.
Comorbidities: no restriction; comorbid conditions are not grounds for exclusion.
IPAF: included if diagnosed as IPF and without a confirmed diagnosis of any collagen vascular disease.
Key exclusion criteria
Studies that enroll patients with active or ongoing acute exacerbation at baseline.
Studies primarily recruiting non-IPF interstitial lung diseases (e.g., confirmed connective tissue disease-associated ILD).
Non-human, pediatric-only, or non-clinical studies that do not match the target patient population.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Horita |
Organization
Yokohama City University Hospital
Division name
Department of Respiratory Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
0457872800
horitano@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Horita |
Organization
Yokohama City University Hospital
Division name
Department of Respiratory Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
0457872800
Homepage URL
horitano@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Respiratory Medicine, Yokohama City University Hospital
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel
0457872800
horitano@yokohama-cu.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
| 2025 | Year | 11 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a systematic review and meta-analysis to validate surrogate endpoints in idiopathic pulmonary fibrosis (IPF). We include randomized controlled trials and relevant studies enrolling IPF patients; possible, probable, and definite IPF are allowed if permitted by the original design. Studies enrolling patients with active or ongoing acute exacerbation at baseline are excluded. The primary outcome is the weighted Pearson correlation coefficient (r) between hazard ratios for exacerbation-based endpoints (HR_ex) and composite survival endpoints (HR_comp) and the hazard ratio for overall survival (HR_OS). Planned sensitivity analyses: (1) definition of exacerbation-based endpoints (time to first exacerbation vs exacerbation-free survival), (2) adjusted vs unadjusted HRs, (3) intervention categories, and (4) risk-of-bias strata. Composite survival endpoints are standardized as death plus at least two of the following: hospitalization, physiologic decline, exacerbation, lung transplantation, or similar major events. Sources to be searched include MEDLINE, Embase, CENTRAL, ClinicalTrials.gov, and ICTRP. No individual-level data will be collected; therefore, ethics review is not required.
Management information
Registered date
| 2025 | Year | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068308
