UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035369 |
|---|---|
| Receipt number | 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 | 2019/06/27 10:22:49 |
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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
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Arakawa |
Organization
The Jikei University School of Medicine
Division name
Medical Oncology and Hematology
Zip code
1058471
Address
3-19-18 Nishi-Shimbashi Minato-ku Tokyo
TEL
03-3433-1111
yarakawa@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Arakawa |
| Middle name | |
| Last name | Yasuhiro |
Organization
The Jikei University School of Medicine
Division name
Medical Oncology and Hematology
Zip code
1058471
Address
3-19-18 Nishi-Shimbashi Minato-ku Tokyo
TEL
03-3433-1111
Homepage URL
yarakawa@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
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
The Jikei University School of Medicine
Address
3-19-18 Nishi-Shinbashi Minato-ku Tokyo
Tel
03-3433-1111
clresuce@jikei.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
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
| 2019 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
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
| 2019 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040289
