UMIN-CTR Clinical Trial

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
Email	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
Email	h-akagi@keiyu-hospital.com

Sponsor
Institute	Keiyu hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051570