UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031464 |
|---|---|
| Receipt number | R000035915 |
| Scientific Title | Genetic analysis long after transplantating autologous oral mucosal epithelial cell sheets |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2018/02/24 21:19:06 |
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Basic information
Public title
Genetic analysis long after transplantating autologous oral mucosal epithelial cell sheets
Acronym
Genetic analysis of the esophagus after transplantating autologous OMECSs
Scientific Title
Genetic analysis long after transplantating autologous oral mucosal epithelial cell sheets
Scientific Title:Acronym
Genetic analysis of the esophagus after transplantating autologous OMECSs
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Genetic safety and tissue construction for the long termafter transplantation of autologous oral mucosal epithelial cell sheets remain unclear.
The aim of study is the establishment of the evaluating system using genetic analysis of profiling cancer-related gene mutations.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Establishment of the evaluating system using genetic analysis of profiling cancer-related gene mutations
Key secondary outcomes
1. mutation rates of whole exon or genome analysis
2. Establishment of the evaluating system using methylation analysis of profiling cancer-related gene
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
Patients with early or advanced esophageal caner
Patients with transplanting autologous oral mucosal epithelial cell sheets
Key exclusion criteria
Patient who cannot attend
Nagasaki University hospital
Endoscopic examination is impossible due to allergic constitution
Endoscopic examination is impossible due to enrolling other intensive clinical researches
Pregnancy
Exclusion by research representative
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Eguchi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Surgery
Zip code
Address
sakamoto, 1-7-1, Nagasaki, Japan
TEL
0958197316
sueguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Kobayashi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Surgery
Zip code
Address
sakamoto, 1-7-1, Nagasaki, Japan
TEL
0958197316
Homepage URL
shinichirokobayashi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 01 | Day |
Other
Other related information
Genetic analysis using cancer panel of esophageal cancer
Management information
Registered date
| 2018 | Year | 02 | Month | 24 | Day |
Last modified on
| 2018 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035915
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
