UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055894 |
|---|---|
| Receipt number | R000063876 |
| Scientific Title | Observational study to evaluate the capability of digital devices to detect drug-induced interstitial pneumonia caused by cancer drug therapy |
| Date of disclosure of the study information | 2024/10/21 |
| Last modified on | 2025/07/24 09:11:29 |
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Basic information
Public title
Observational study to evaluate the capability of digital devices to detect drug-induced interstitial pneumonia caused by cancer drug therapy
Acronym
Observational study using digital devices for drug-induced interstitial pneumonia
Scientific Title
Observational study to evaluate the capability of digital devices to detect drug-induced interstitial pneumonia caused by cancer drug therapy
Scientific Title:Acronym
Observational study using digital devices for drug-induced interstitial pneumonia
Region
| Japan |
Condition
Condition
Patients with drug-induced interstitial pneumonia caused by cancer drug therapy
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the capability of digital devices to detect drug-induced interstitial pneumonia caused by cancer drug therapy.
To evaluate the capability of the device to detect abnormal respiratory sounds in patients with drug-induced interstitial pneumonia and to evaluate its validity for future observational studies.
Basic objectives2
Others
Basic objectives -Others
The capability of digital devices to detect drug-induced interstitial pneumonia caused
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity of digital devices to fine crackles
Key secondary outcomes
- Positive predictive value of digital devices to fine crackles
- Sensitivity of digital devices to adventitious sound
- Positive predictive value of digital devices to adventitious sound
- Percentage of concordance between the results of the detection of adventitious sound by a respiratory specialist obtained by the researcher and those obtained by the patients or their care giver
- Percentage of concordance between the results of the detection of adventitious sound by digital devices obtained by the researcher and those obtained by the patients or their care giver
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) Patients who are at least 18 years of age at the time of informed consent
2) Patients diagnosed with cancer
3) Patients with drug-induced interstitial pneumonia caused by cancer drug therapy
4) Patients who the investigators determine that patients or their caregivers can use the digital devices* for measurements in the study
5) Patients who provided informed consent to participate in the study
*Android smart phone for the study, abnormal respiratory sounds detection device
Key exclusion criteria
1) Patients who are determined by the investigators to be ineligible because of psychological disorders that may affect the use of the digital devices* in the study
2) Patients who are determined by the investigators to have respiratory complications** that may affect the measurement results of the digital devices* in the study
3) Patients who are scheduled to travel overseas during participation in the study
4) Patients who are determined by the investigators to be ineligible for participate in the study for any reason
*Android smart phone for the study, abnormal respiratory sounds detection device
**Respiratory diseases that produce fine crackles, such as pulmonary fibrosis and mycoplasma pneumonia
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Goto |
Organization
National Cancer Center Hospital
Division name
Department of Thoracic Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
ygoto@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Suzuki |
Organization
Mebix, Inc.
Division name
Clinical Operations
Zip code
105-0001
Address
Toranomon 33 Mori Building 3-8-21 Toranomon, Minato-ku, Tokyo, 105-0001, Japan
TEL
03-4362-4500
Homepage URL
ild-samd_pilot@mebix.co.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO COMPANY, LIMITED.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
AIR WATER INC.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Ethics Committee
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan 104-0045
Tel
03-3542-2511
irst@ml.res.ncc.go.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
| 2024 | Year | 10 | 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
3
Results
The number of patients enrolled in the study was significantly less than the target number of three, as the progress in enrollment was not as expected. Three patients were not analyzed for the primary and secondary endpoints, as a statistically significant analysis was not possible.
Results date posted
| 2025 | Year | 07 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All three patients (two men and one woman) had no respiratory complications or history of disease. All three patients had at least one lung cancer lesion or a metastatic site.
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 04 | Month | 07 | Day |
Date trial data considered complete
| 2025 | Year | 05 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
-Prospective, observational study.
-All patients who have obtained free and informed consent in writing from the individual who visited National Cancer Center Hospital between October 1, 2024 and March 31, 2025 (planned), and who meet the inclusion criteria, and do not meet the exclusion criteria.
-Observation and examination items include patient background and comorbidities, laboratory tests, vitals, and respiratory sounds obtained via the device.
Management information
Registered date
| 2024 | Year | 10 | Month | 21 | Day |
Last modified on
| 2025 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063876
