UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045141 |
|---|---|
| Receipt number | R000051570 |
| Scientific Title | A prospective observational study of ocular findings in immune checkpoint inhibitor recipients |
| Date of disclosure of the study information | 2021/08/13 |
| Last modified on | 2021/08/12 16:57:39 |
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Basic information
Public title
A prospective observational study of ocular findings in immune checkpoint inhibitor recipients
Acronym
A prospective observational study of ocular findings in immune checkpoint inhibitor recipients
Scientific Title
A prospective observational study of ocular findings in immune checkpoint inhibitor recipients
Scientific Title:Acronym
A prospective observational study of ocular findings in immune checkpoint inhibitor recipients
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Immune checkpoint inhibitors treat cancer by activating immunity. While this drug has revolutionized the treatment of cancers such as malignant melanoma, renal cell carcinoma, lung cancer, and gastric cancer, activation of immunity causes autoimmune diseases in all organs throughout the body. Side effects called immune-related adverse events include interstitial pneumonia, hypothyroidism, diabetes, pituitary dysfunction, etc., and uveitis appears in the eye. Uveitis has a wide range of inflammation, from those who are aware of mild blurred vision to those who have markedly impaired vision. In the previous reports, there are some cases in which visual function was improved by topical or systemic administration of steroids, but the number of reports is small worldwide and there are many unclear points. The indications for immune checkpoint inhibitors are expected to expand in the future. It is desirable for the patient to maintain the Quality of Vision while continuing to take the medication. This time, we will conduct this study with the aim of obtaining information on the time of occurrence of side effects, the mode of occurrence, the risk of onset. The purpose is to utilize it for early detection and early treatment of side effects of medication patients in the future.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of ocular findings and how to treat them
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients who have treatment of Immune check point inhibitors are seen by an ophthalmologist before and after the start of dosing. Follow-up will be performed 1 month after administration, every 2 months thereafter, and 1 year after the start of administration.
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Since August 1st in 2020, for the patient to start the administration of the agent of the immune checkpoint inhibitors in Keiyu hospital.
Key exclusion criteria
Exclude if there is a reason such as general condition that cannot be examined or examined by an ophthalmologist.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koutaro |
| Middle name | |
| Last name | Suzuki |
Organization
Keiyu hospital
Division name
Ophthalmology and Oncology
Zip code
2208521
Address
3-7-3, Minatomirai, Nishi-ku, Yokohama,
TEL
0452218181
h-akagi@keiyu-hospital.com
Public contact
Name of contact person
| 1st name | Hideko |
| Middle name | |
| Last name | Akagi |
Organization
Keiyu hospital
Division name
Oncology
Zip code
2208521
Address
3-7-3 Minatomirai, Nishi-ku, Yokohama
TEL
0452218181
Homepage URL
h-akagi@keiyu-hospital.com
Sponsor or person
Institute
Keiyu hospital
Institute
Department
Personal name
Funding Source
Organization
Keiyu hospital
Ophthalmology and Oncology
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
Keiyu hospital
Address
3-7-3 Minatomirai, Nishi-ku, Yokohama
Tel
0452218181
h-akagi@keiyu-hospital.com
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
| 2021 | Year | 08 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 12 | Day |
Last modified on
| 2021 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051570
| Research Plan | |
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| Registered date | File name |
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