UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060497 |
|---|---|
| Receipt number | R000067458 |
| Scientific Title | A Real-world Survey on Treatment and Prognosis Following Primary Lung Cancer Development in Patients with Interstitial Lung Disease Undergoing Antifibrotic Therapy: A Multicenter Retrospective Study |
| Date of disclosure of the study information | 2026/02/02 |
| Last modified on | 2026/01/28 13:28:19 |
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Basic information
Public title
A Real-world Survey on Treatment and Prognosis Following Primary Lung Cancer Development in Patients with Interstitial Lung Disease Undergoing Antifibrotic Therapy: A Multicenter Retrospective Study
Acronym
A Real-world Survey on the Actual Situation Following Primary Lung Cancer Development in ILD Patients Receiving Antifibrotic Therapy
Scientific Title
A Real-world Survey on Treatment and Prognosis Following Primary Lung Cancer Development in Patients with Interstitial Lung Disease Undergoing Antifibrotic Therapy: A Multicenter Retrospective Study
Scientific Title:Acronym
A Real-world Survey on the Actual Situation Following Primary Lung Cancer Development in ILD Patients Receiving Antifibrotic Therapy
Region
| Japan |
Condition
Condition
Primary lung cancer with interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the therapeutic interventions and prognostic outcomes in patients with primary lung cancer who also have interstitial lung disease while undergoing antifibrotic drug therapy.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival from the diagnosis of primary lung cancer
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
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age: 20 years or older
2. Patients diagnosed with any interstitial lung disease
3. Patients who have been on antifibrotic therapy for 3 months or longer
4. Patients diagnosed with primary lung cancer while receiving antifibrotic therapy
Key exclusion criteria
1. Patients not receiving antifibrotic drugs for ILD
2. Patients with interstitial changes of 10% or less on chest HRCT (ILA patients)
3. Patients in which anti-fibrotic drugs for ILD were discontinued, followed by the development of primary lung cancer
4. Patients in which anti-fibrotic drugs were initiated after diagnosis of primary lung cancer
5. Patients in which anticancer drugs were administered for primary lung cancer prior to anti-fibrotic drug administration
6. Drug-induced ILD
7. Patients deemed unsuitable as study subjects by the principal investigator
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
1138431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
mtkatou@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Motoyasu |
| Middle name | |
| Last name | Kato |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
1138431
Address
3-1-3, Hongo, Bunkyo-ku,Tokyo
TEL
0338133111
Homepage URL
mtkatou@juntendo.ac.jp
Sponsor or person
Institute
Labour and Welfare Research Group on Diffuse Lung Diseases in Ministry of Health
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel
0338133111
mtkatou@juntendo.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
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 02 | 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 | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2026 | Year | 01 | Month | 28 | Day |
Last modified on
| 2026 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067458
