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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030435
Receipt No. R000034753
Scientific Title Investigation of reaction of large intestine subcutaneous myofibroblasts to inflammatory cytokines.
Date of disclosure of the study information 2017/12/17
Last modified on 2018/08/20

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Basic information
Public title Investigation of reaction of large intestine subcutaneous myofibroblasts to inflammatory cytokines.
Acronym cMFCulture
Scientific Title Investigation of reaction of large intestine subcutaneous myofibroblasts to inflammatory cytokines.
Scientific Title:Acronym cMFCulture
Region
Japan

Condition
Condition Ulcerative colitis, Crohn's disease, Colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We isolated and cultured myofibroblasts (Colonic myofibroblast; cMF) from ulcerative colitis and Crohn's disease patients and normal submucosal layers, stimulated with cytokines and chemokines, and examined the reaction by qPCR, It aims to clarify the mechanism.
Basic objectives2 Others
Basic objectives -Others Cell isolation and culture.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analysis of expression induced genes. Quantitative analysis by qPCR.
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
75 years-old >
Gender Male and Female
Key inclusion criteria Ulcerative colitis in our hospital outpatient clinic and hospitalization, patients with Crohn 's disease who were supposed to resect small intestine or large intestine by surgical operation. And patients who had to resect the small intestine or large intestine by surgical operation due to colorectal cancer and small bowel cancer at our hospital.
Key exclusion criteria 1) Patients who have complications of infections that require notification under the Infectious Diseases Act.
2) Patients who had a positive margin during intraoperative rapid pathological diagnosis.
3) When patients with colorectal cancer or small intestine cancer are suspected of direct invasion outside the organ due to laparotomy findings.
4) If the tissue to be excised for this study after resection for pathologic diagnosis is not 2 cm or more away from the tumor site, it is excluded from this study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotsugu Imaeda
Organization Shiga University of Medical Science
Division name Division of Gastroenterology
Zip code
Address Setatsukinowa-cho, Otsu
TEL 077-548-2217
Email imaeda@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirotsugu Imaeda
Organization Shiga University of Medical Science
Division name Division of Gastroenterology
Zip code
Address Setatsukinowa-cho, Otsu
TEL 077-548-2217
Homepage URL
Email imaeda@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
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
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 12 Month 17 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
2015 Year 06 Month 09 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Isolated cultured cells are stimulated with cytokines, mRNA is collected and microarray is performed. We investigated the greatly changed gene by qPCR.

Management information
Registered date
2017 Year 12 Month 17 Day
Last modified on
2018 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034753

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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