UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044558 |
|---|---|
| Receipt number | R000050901 |
| Scientific Title | Commonality of gene mutations in hypopharyngeal and esophageal cancer |
| Date of disclosure of the study information | 2021/06/21 |
| Last modified on | 2021/06/16 13:42:00 |
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Basic information
Public title
Commonality of gene mutations in hypopharyngeal and esophageal cancer
Acronym
Gene mutations in hypopharyngeal and esophageal cancer
Scientific Title
Commonality of gene mutations in hypopharyngeal and esophageal cancer
Scientific Title:Acronym
Gene mutations in hypopharyngeal and esophageal cancer
Region
| Japan |
Condition
Condition
double cancer, hypopharyngeal and esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We comprehensively analyze gene mutations in double cancers of hypopharyngeal squamous cell carcinoma and esophageal squamous cell carcinoma, and examine the commonality of their properties related to tumor growth and infiltration.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Commonality of gene mutation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Double cancers of hypopharynx and esophagus that were treated with radical surgery from January 1, 2010 to December 31, 2020 at Kobe University Hospital and Hyogo Cancer Center.
Surgical pathological specimens are available.
The pathological results of both hypopharyngeal cancer and esophageal cancer are squamous cell carcinoma.
Key exclusion criteria
Patients who offered not to participate in this study based on the published information
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Nibu |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
650-0017
Address
7-5-2 Kusunokicho Chuo-ku, Kobe, Hyogo 650-0017 Japan
TEL
078-382-5111
nibu@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Shinomiya |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
650-0017
Address
7-5-2 Kusunokicho Chuo-ku, Kobe, Hyogo 650-0017 Japan
TEL
078-382-5111
Homepage URL
hshino@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan science and technology agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe Univ. Hosp. Clin Transl Res Center
Address
7-5-2 Kusunokicho Chuo-ku, Kobe, Hyogo 650-0017 Japan
Tel
078-382-6669
chiken@med.kobe-u.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 06 | Month | 16 | Day |
Last modified on
| 2021 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050901
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| Registered date | File name |
| Research case data | |
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