UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027365 |
|---|---|
| Receipt number | R000031339 |
| Scientific Title | Analysis of pathogenic mechanism of colorectal sessile serrated adenoma/polyp and hyperplastic polyp : clarification of molecular basis by gene expression profiling |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2017/06/01 16:28:26 |
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Basic information
Public title
Analysis of pathogenic mechanism of colorectal sessile serrated adenoma/polyp and hyperplastic polyp : clarification of molecular basis by gene expression profiling
Acronym
Gene expression profiling of colorectal sessile serrated adenoma/polyp and hyperplastic polyp
Scientific Title
Analysis of pathogenic mechanism of colorectal sessile serrated adenoma/polyp and hyperplastic polyp : clarification of molecular basis by gene expression profiling
Scientific Title:Acronym
Gene expression profiling of colorectal sessile serrated adenoma/polyp and hyperplastic polyp
Region
| Japan |
Condition
Condition
colorectal sessile serrated adenoma/polyp (SSA/P) and colorectal hyperplastic polyp (HP)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our first research objects are to investigate gene expression profiling of SSA/P and HP, to identify specific marker genes according to gene expression profiling, to investigate genetic analyses such as BRAF mutation, DNA methylation, and microsatellite instability, and to analyze expression pattern of micro RNA.
Basic objectives2
Others
Basic objectives -Others
Our final objectives are to investigate malignant potential of SSA/P and HP using results of first research objects, and to evaluate difference of SSA/P and HP.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gene expression profiling and genetic analyses of SSA/P and HP
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All cases which were diagnosed as sessile serrated adenoma/polyp or hyperplastic polyp by endoscopy or histopathologic examination.
Key exclusion criteria
Cases such as medical history of surgical removal of colorectal, duplicated malignant disease, familial adenomatous polyposis, inflammatory bowel disease, minor/elderly person/handicapped person who is needed special consideration, cases which were not diagnosed as sessile serrated adenoma or hyperplastic polyp.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobutake Yamamichi |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology, Graduate School of Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
nyamamic-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Oki |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology, Graduate School of Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411ext.34718
Homepage URL
daisuke-oki@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo Hospital
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
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
| 2017 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | 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
We perform biopsy from lesion and background normal colorectal mucosa one by one before endoscopic resection of SSA/P and HP.
After biopsy, we perform endoscopic resection and then confirm pathological diagnosis. We extract RNA and DNA from biopsy tissue. Then we perform gene expression profiling by mRNA microarray and investigate genetic analysis usingextraced DNA.
Management information
Registered date
| 2017 | Year | 05 | Month | 16 | Day |
Last modified on
| 2017 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031339
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
