UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030435 |
|---|---|
| Receipt number | 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 06:58:50 |
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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
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
imaeda@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034753
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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