UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045169 |
|---|---|
| Receipt number | R000051600 |
| Scientific Title | Reduction of side effects of tongue cancer radiotherapy with encapsulated sealed radioactive source by using mouth spacer systems |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2021/08/16 19:04:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical research on the reduction of side effects of tongue cancer radiotherapy with encapsulated sealed radioactive source by using mouth spacer systems
Acronym
Protective effects of mouth spacer systems on tongue cancer radiotherapy
Scientific Title
Reduction of side effects of tongue cancer radiotherapy with encapsulated sealed radioactive source by using mouth spacer systems
Scientific Title:Acronym
Protective effects of mouth spacer systems on tangue cancer radiotherapy
Region
| Japan |
Condition
Condition
tongue cancer
Classification by specialty
| Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the reduction of side effects of tongue cancer radiotherapy with encapsulated sealed radioactive source, by using mouth guard systems.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Reduction of side effects of tongue cancer radiotherapy with encapsulated sealed radioactive source.
Key secondary outcomes
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
Patients with tongue cancer treated by radiotherapy with encapsulated sealed radioactive source at Tohoku University Hospital.
Key exclusion criteria
Patients with tongue cancer spread over the marginal area of tongue.
Patients who dose not agree to enroll to this study.
Target sample size
20
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
Division of preventive Dentistry
Zip code
980-8575
Address
4-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, 980-8575, JAPAN
TEL
022-717-8327
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
Division of preventive Dentistry
Zip code
980-8575
Address
4-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, 980-8575, JAPAN
TEL
022-717-8327
Homepage URL
tkoseki@dent.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Management grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Tohoku University Graduate School of Dentistry
Address
4-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, 980-8575, JAPAN
Tel
022-717-8244
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | 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
| 2021 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation of occurance of side effects of radiotherapy
Management information
Registered date
| 2021 | Year | 08 | Month | 16 | Day |
Last modified on
| 2021 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051600
