UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014573 |
|---|---|
| Receipt number | R000016951 |
| Scientific Title | Investigation of oral mucositis during chemotherapy for esophageal cancer |
| Date of disclosure of the study information | 2014/07/17 |
| Last modified on | 2018/04/05 13:28:31 |
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Basic information
Public title
Investigation of oral mucositis during chemotherapy for esophageal cancer
Acronym
chemotherapy for esophageal cancer and oral mucositis
Scientific Title
Investigation of oral mucositis during chemotherapy for esophageal cancer
Scientific Title:Acronym
chemotherapy for esophageal cancer and oral mucositis
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation of stomatitis incidence of esophageal cancer during chemotherapy
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
oral mucositis incidence
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
none
Key exclusion criteria
none
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Tanaka |
Organization
Gifu university
Division name
Surgical oncology
Zip code
Address
1-1 Yanagido Gifu city
TEL
0582306000
yoshihirotana11@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Tanaka |
Organization
Gifu Univ. Medicine
Division name
Surgical Oncology
Zip code
Address
1-1 Yanagido Gifu city
TEL
0582306000
Homepage URL
yoshihirotana11@hotmail.com
Sponsor or person
Institute
Surgical oncology1 Gifu Univarsity school of medicine
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Pharmaceuticals Co.,Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 07 | Month | 17 | 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
| 2012 | Year | 12 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2014 | Year | 07 | Month | 16 | Day |
Last modified on
| 2018 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016951
