UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024927 |
|---|---|
| Receipt number | R000028678 |
| Scientific Title | The prospective picture cllection study of mucositis induced by radiotherapy |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2023/05/29 07:44:22 |
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Basic information
Public title
The prospective picture cllection study of mucositis induced by radiotherapy
Acronym
Mucositis grading ATLAS
Scientific Title
The prospective picture cllection study of mucositis induced by radiotherapy
Scientific Title:Acronym
Mucositis grading ATLAS
Region
| Japan |
Condition
Condition
Head and Neck Cancer
Classification by specialty
| Oto-rhino-laryngology | Radiology | Oral surgery |
| Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To make mucositis grading ATLAS
Basic objectives2
Others
Basic objectives -Others
To make TEXT using mucositis grading ATLAS
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Picture collection >1000 pictures
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Head and Neck cancer patients
Plan to receive radiotherapy
Can understand about informed consent
Can open mouth enough to be taken pictures
Key exclusion criteria
none
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sadamoto Zenda |
Organization
National Cancer Center Hospital East
Division name
Radiation Oncology
Zip code
Address
6-5-1 Kashiwanoha Kashiwa, Chiba, Japan 277-8577
TEL
+81-4-7133-1111
szenda@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sadamoto Zenda |
Organization
National Cancer Center Hospital East
Division name
Radiation Oncology
Zip code
Address
6-5-1 Kashiwanoha Kashiwa Chiba, Japan 277-8577
TEL
+81-4-7133-1111
Homepage URL
szenda@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Address
Tel
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
| 2016 | Year | 12 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This prospective cohort is managed by 9 institutions-collaboration
Management information
Registered date
| 2016 | Year | 11 | Month | 21 | Day |
Last modified on
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028678
