UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019174 |
|---|---|
| Receipt number | R000020775 |
| Scientific Title | Analysis of inflammatory bowel disease by using endoscopic biopsy specimen |
| Date of disclosure of the study information | 2015/10/15 |
| Last modified on | 2023/03/09 15:16:39 |
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Basic information
Public title
Analysis of inflammatory bowel disease by using endoscopic biopsy specimen
Acronym
Analysis of inflammatory bowel disease by using endoscopic biopsy specimen
Scientific Title
Analysis of inflammatory bowel disease by using endoscopic biopsy specimen
Scientific Title:Acronym
Analysis of inflammatory bowel disease by using endoscopic biopsy specimen
Region
| Japan |
Condition
Condition
Crohn's disease, ulcerative colitis, and other inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
epidemiological study of inflammatory bowel disease
Basic objectives2
Others
Basic objectives -Others
elucidation of inflammatory bowel disease pathogenesis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of the gene expression in the intestinal epithelia between an inflammatory bowel disease and noninflammatory bowel disease patients
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1, men and women, whose age at the time of the agreement acquisition are 20 years or older
2, the patients who are going to out patient department or are in hospital
3, the patients who are obtained the agreement in documents about the participation of this study
Key exclusion criteria
1, the patients who are desirable to avoid an biopsy
2, the patients with severe anemia (serum hemoglobin level less than 10 g/dL)
3, the patients with psychological disorder, epilepsy, cardiovascular disease, hemophilia and severe diabetes mellitus
4, the patient who admitted that it was inappropriate to participate in this study by primary doctors
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryohei Hayashi |
Organization
Hiroshima University Hospital
Division name
Department of Endoscopy
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-1733
ibd@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryohei Hayashi |
Organization
Hiroshima University Hospital
Division name
Department of Endoscopy
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-1733
Homepage URL
ibd@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital, Department of Endoscopy
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University Hospital, Department of Endoscopy
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
| 2015 | Year | 10 | Month | 15 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment of target people: patients who are performed gastrointestinal endoscopy in Hiroshima University Hospital between 15th Sep. 2015 and 31th Mar. 2018
Management information
Registered date
| 2015 | Year | 09 | Month | 30 | Day |
Last modified on
| 2023 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020775
