UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063303 |
|---|---|
| Receipt number | R000070703 |
| Scientific Title | Prospective observational study to evaluate Datopotamab deruxtecan-related ocular surface events and supportive care (WJOG21625B) |
| Date of disclosure of the study information | 2026/10/16 |
| Last modified on | 2026/10/16 09:15:06 |
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Basic information
Public title
Prospective observational study of eye problems associated with Datopotamab deruxtecan treatment (WJOG21625B)
Acronym
VISION study(WJOG21625B)
Scientific Title
Prospective observational study to evaluate Datopotamab deruxtecan-related ocular surface events and supportive care (WJOG21625B)
Scientific Title:Acronym
VISION study(WJOG21625B)
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the incidence and severity of Datopotamab deruxtecan related ocular adverse events
Basic objectives2
Others
Basic objectives -Others
Secondary objectives
- To evaluate the risk factors for ocular surface events associated with Dato-DXd treatment.
- To evaluate the association between supportive care practices for ocular surface events during Dato-DXd treatment and the occurrence of ocular surface events.
- To evaluate the association between patient self-care practices for ocular surface events and the occurrence of ocular surface events in patients receiving Dato-DXd treatment.
- To evaluate the incidence of adverse events associated with Dato-DXd treatment.
- To evaluate treatment persistence and reasons for discontinuation in patients receiving Dato-DXd treatment.
- To evaluate the clinical course of Grade >=3 ocular surface events.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ocular surface events (diagnosis and Grade)
Dry-eye symptoms (J-OSDI total and subscale scores)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed breast cancer.
2) Unresectable or metastatic breast cancer.
3) Aged >=18 years at the time of informed consent.
4) No prior treatment with Dato-DXd.
5) Planned initiation of Dato-DXd treatment within 28 days after enrollment.
6) Able to complete electronic patient-reported outcome (ePRO) assessments.
7) Provided written informed consent prior to study enrollment after receiving a full explanation of the study.
Key exclusion criteria
1) History of hypersensitivity to any component of Dato-DXd.
2) Clinically significant corneal disease.
3) Any condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Sakai |
Organization
SHOWA Medical University
Division name
Advanced Cancer Translational Research Institute
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666
TEL
03-3784-8146
sakai-h@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ishizuka |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SHOWA Medical University Research Ethics Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666
Tel
03-3784-8129
m-rinri@ofc.showa-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 16 | 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 | 04 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2029 | Year | 11 | Month | 30 | Day |
Other
Other related information
To investigate the incidence, severity, and risk factors of ocular surface events associated with Dato-DXd treatment. In addition, as exploratory analyses, the feasibility of anterior segment imaging using the Smart Eye Camera and the concentration of Dato-DXd in tears will be evaluated.
Management information
Registered date
| 2026 | Year | 10 | Month | 16 | Day |
Last modified on
| 2026 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070703
