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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035369
Receipt No. R000040289
Scientific Title The association between ADH1B and ALDH2 genotypes and the prognosis and effect of treatment in esophageal cancer patients.
Date of disclosure of the study information 2019/01/01
Last modified on 2018/12/26

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Basic information
Public title The association between ADH1B and ALDH2 genotypes and the prognosis and effect of treatment in esophageal cancer patients.
Acronym The association between ADH1B and ALDH2 genotypes and the prognosis and effect of treatment in esophageal cancer patients.
Scientific Title The association between ADH1B and ALDH2 genotypes and the prognosis and effect of treatment in esophageal cancer patients.
Scientific Title:Acronym The association between ADH1B and ALDH2 genotypes and the prognosis and effect of treatment in esophageal cancer patients.
Region
Japan

Condition
Condition esophageal squamous cell carcinoma
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 investigate the association between ALDH1B, ALDH2 genotypes and the prognosis and effect of treatment in patients with esophageal cancer.
Basic objectives2 Others
Basic objectives -Others observational Study
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes overall survival
Key secondary outcomes progression-free survival, relapse-free survival, response rate, secondary primary malignancies

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria pathologically proven esophageal cancer patients who give written consent to participate in this study
Key exclusion criteria patients who do not treat esophageal caner, minors, patients who can not give consent
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Arakawa
Organization The Jikei University School of Medicine
Division name Medical Oncology and Hematology
Zip code
Address 3-19-18 Nishi-Shimbashi Minato-ku Tokyo
TEL 03-3433-1111
Email yarakawa@jikei.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yasuhiro Arakawa
Organization The Jikei University School of Medicine
Division name Medical Oncology and Hematology
Zip code
Address 3-19-18 Nishi-Shimbashi Minato-ku Tokyo
TEL 03-3433-1111
Homepage URL
Email yarakawa@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization The Jikei University School of Medicine
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
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 東京慈恵会医科大学附属病院 (東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information primary endpoint: overall survival
secondary endpoint: progression-free survival, relapse-free survival, efficacy of treatment, development of secondary primary cancers

Management information
Registered date
2018 Year 12 Month 26 Day
Last modified on
2018 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040289

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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