UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047223 |
|---|---|
| Receipt number | R000053858 |
| Scientific Title | Genome sequence and gene expression analysis using formalin-fixed paraffin-embedded samples of gastrointestinal epithelial tumors and elucidation of the mechanism of gastrointestinal epithelial tumor development using immunostaining and in situ hybridization |
| Date of disclosure of the study information | 2022/03/18 |
| Last modified on | 2025/03/21 19:05:45 |
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Basic information
Public title
Genome sequence and gene expression analysis using formalin-fixed paraffin-embedded samples of gastrointestinal epithelial tumors and elucidation of the mechanism of gastrointestinal epithelial tumor development using immunostaining and in situ hybridization
Acronym
Genome sequence and gene expression analysis using formalin-fixed paraffin-embedded samples of gastrointestinal epithelial tumors
Scientific Title
Genome sequence and gene expression analysis using formalin-fixed paraffin-embedded samples of gastrointestinal epithelial tumors and elucidation of the mechanism of gastrointestinal epithelial tumor development using immunostaining and in situ hybridization
Scientific Title:Acronym
Genome sequence and gene expression analysis using formalin-fixed paraffin-embedded samples of gastrointestinal epithelial tumors and elucidation of the mechanism of gastrointestinal epithelial tumor development using immunostaining and in situ hybridization
Region
| Japan |
Condition
Condition
Gastrointestinal epithelial tumors
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
the main purpose of this study is to perform genome sequencing and gene expression analysis using gastrointestinal epithelial tumor samples, and to identify genes that are useful for diagnosis and as biomarkers. Furthermore, the final goal of this study is to elucidate the molecular basis of gastrointestinal epithelial tumors and to elucidate the mechanism of tumorization based on pathological studies using immunostaining and in situ hybridization of each gene.
Basic objectives2
Others
Basic objectives -Others
Verification of expression level using immunostaining and in situ hybridization
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whole genome sequence and comprehensive gene expression analysis (coded genes, non-coding genes)
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
Samples that have been biopsied or endoscopically (EMR or ESD) or surgically removed at the University of Tokyo Hospital, and already formalin-fixed paraffin-embedded specimens are used.
Key exclusion criteria
None
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Nobutake |
| Middle name | |
| Last name | Yamamichi |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
113-8655
Address
Bunkyo-ku Hongou 7-3-1, Tokyo, JAPAN
TEL
03-3815-5411
nobutakeyamamichi@gmail.com
Public contact
Name of contact person
| 1st name | Chihiro |
| Middle name | |
| Last name | Takeuchi |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
113-8655
Address
Bunkyo-ku Hongou 7-3-1, Tokyo, JAPAN
TEL
03-3815-5411
Homepage URL
goodjob951@gmail.com
Sponsor or person
Institute
The University of Tokyo
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
The University of Tokyo
Address
Bunkyo-ku Hongou 7-3-1, Tokyo, JAPAN
Tel
03-3815-5411
ethics@m.u-tokyo.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
| 2022 | Year | 03 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2027 | 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
| 2022 | Year | 03 | Month | 18 | Day |
Last modified on
| 2025 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053858
