UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062986 |
|---|---|
| Receipt number | R000072095 |
| Scientific Title | Integrated Analysis of Clinical Samples in Trastuzumab Deruxtecan (Enhertu)-Associated Interstitial Lung Disease |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/09/29 20:05:56 |
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Basic information
Public title
A Study of Trastuzumab Deruxtecan-Associated Interstitial Lung Disease Using Bronchoalveolar Lavage Fluid, Blood, and Other Clinical Samples
Acronym
T-DXd-ILD Study
Scientific Title
Integrated Analysis of Clinical Samples in Trastuzumab Deruxtecan (Enhertu)-Associated Interstitial Lung Disease
Scientific Title:Acronym
T-DXd-ILD Study
Region
| Japan |
Condition
Condition
Trastuzumab deruxtecan (T-DXd)-associated interstitial lung disease/pneumonitis
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Conducting integrative analyses using samples such as bronchoalveolar lavage fluid (BALF) and plasma from patients with T-DXd-related interstitial lung disease, elucidating the molecular pathology occurring locally in the lungs, and investigating pathological mechanisms and candidate biomarkers.
Basic objectives2
Others
Basic objectives -Others
Exploratory investigation of disease mechanisms and candidate biomarkers
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification of lung-specific molecular signatures associated with T-DXd-related ILD by comparing proteomic profiles of BALF among patients with T-DXd-related ILD, patients with non-drug-related interstitial lung disease, and healthy-lung controls.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
All participants are scheduled to undergo bronchoscopy for clinical purposes. In the T-DXd-related ILD group and the non-drug-related ILD control group, BALF obtained for clinical purposes will be used for research. In the healthy-lung control group, BALF will be additionally collected for research purposes during the clinically scheduled bronchoscopy from a lung segment without obvious pneumonia, interstitial opacities, or tumor infiltration. Research-related BALF collection will be performed once. All other medical care will follow routine clinical practice.
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 informed consent.
2. Written informed consent has been obtained.
3. Bronchoscopy is scheduled for clinical purposes, and participation involving BALF collection is medically feasible.
4. The participant meets the criteria for one of the following groups:
[T-DXd-related ILD group] New pulmonary opacities or worsening of pre-existing opacities during or after T-DXd treatment, with T-DXd-related ILD
suspected by a respiratory specialist.
[Non-drug-related ILD control group] No history of T-DXd treatment; non-drug-related ILD present or suspected; and resting SpO2 greater than 90%.
[Healthy-lung control group] No history of T-DXd treatment; bronchoscopy planned for diagnosis of early lung cancer or a localized pulmonary lesion;
and BALF can be obtained from a lung region without obvious pneumonia, interstitial opacities, or tumor infiltration.
Key exclusion criteria
Individuals with an active, severe infection for whom collecting additional samples for research purposes is deemed inappropriate.
Individuals with T-DXd-related ILD whose pulmonary opacities can be clearly attributed to causes other than T-DXd, such as infection, tumor progression, carcinomatous lymphangitis, heart failure, radiation pneumonitis, or drug-induced lung injury.
Individuals otherwise deemed unsuitable for participation in this study by the principal investigator or a sub-investigator.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | ISAO |
| Middle name | |
| Last name | ITO |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
371-8511
Address
3-39-15 Showa-machi Maebashi city, Gunma, Japan
TEL
0272208000
isaoito@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | YASUHIKO |
| Middle name | |
| Last name | KOGA |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
371-8511
Address
3-39-15 Showa-machi Maebashi city, Gunma, Japan
TEL
0272208000
Homepage URL
ykoga@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
AstraZeneca K.K.
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-machi Maebashi city, Gunma, Japan
Tel
0272208747
Irb-jimukk-ciru@ml.gunma-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
群馬大学医学部附属病院、前橋赤十字病院、高崎総合医療センター
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 18 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072095
