UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041688 |
|---|---|
| Receipt number | 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 19:03:36 |
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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
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
tkoseki@dent.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047577
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
