UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study of oral adverse events by anti-cancer therapy with immune checkpoint inhibitors
Acronym	Study of oral adverse events by using immune checkpoint inhibitors
Scientific Title	Prospective study of oral adverse events by anti-cancer therapy with immune checkpoint inhibitors
Scientific Title:Acronym	Study of oral adverse events by using immune checkpoint inhibitors
Region	Japan

Condition
Condition	Oral mucositis
Classification by specialty	Dental medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the oral adverse events during anti-cancer therapiy using immune checkpoint inhibitor.
Basic objectives2	Others
Basic objectives -Others	Observational study
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Grade of oral oral mucositis
Key secondary outcomes	Examination of dental condition

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients who suffer oral adverse events during cancer treatments with immune checkpoint inhibitors
Key exclusion criteria	The patients who are unable to get informed consent
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takeyoshi Middle name Last name Koseki
Organization	Tohoku University Graduate School of Dentistry
Division name	Preventive Dentistry
Zip code	980-8575
Address	4-1, Seiryomachi, Aobaku, Sendai, Miyagi
TEL	0227178327
Email	tkoseki@dent.tohoku.ac.jp

Public contact
Name of contact person	1st name Takeyoshi Middle name Last name Koseki
Organization	Tohoku University Graduate School of Dentistry
Division name	Preventive Dentistry
Zip code	980-8575
Address	4-1, Seiryomachi, Aobaku, Sendai, Miyagi
TEL	0227178327
Homepage URL
Email	tkoseki@dent.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	National Cancer Center Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Tohoku University Graduate School of Dentistry
Address	4-1, Seiryomachi, Aobaku, Sendai, Miyagi
Tel	0227178244
Email	den-syom@grp.tohoku.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	東北大学病院（宮城県） 国立がん研究センター中央病院（東京都）

Other administrative information
Date of disclosure of the study information	2020 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	2020 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2021 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	In addition to the routine clinical treatments, we exam the following tests: level of xerostomia, impaired taste, tongue coating, and level of oral pain.

Management information
Registered date	2020 Year 09 Month 04 Day
Last modified on	2020 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047577