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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041688
Receipt No. R000047577
Scientific Title Prospective study of oral adverse events by anti-cancer therapy with immune checkpoint inhibitors
Date of disclosure of the study information 2020/11/01
Last modified on 2020/09/04

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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