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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014573
Receipt No. 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

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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
Email 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
Email yoshihirotana11@hotmail.com

Sponsor
Institute Surgical oncology1 Gifu Univarsity school of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016951

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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