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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027365
Receipt No. 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

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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
Email 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
Email daisuke-oki@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031339

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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