UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015493 |
|---|---|
| Receipt number | R000017999 |
| Scientific Title | The new diagnosis method using nanobecon for colitis associated carcinoma |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2019/04/25 14:16:24 |
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Basic information
Public title
The new diagnosis method using nanobecon for colitis associated carcinoma
Acronym
The new diagnosis method for colitis associated carcinoma
Scientific Title
The new diagnosis method using nanobecon for colitis associated carcinoma
Scientific Title:Acronym
The new diagnosis method for colitis associated carcinoma
Region
| Japan |
Condition
Condition
Ulcerative colitis
Colon carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of new diagnosis method using nanobecon for colitis associated carcinoma
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The efficacy of new diagnosis method using nanobecon for colitis associated carcinoma
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Conventional historogical examaination
Interventions/Control_2
New immunohistochemisty using nanobecon
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with colon carcinoma or ulcerative colitis
Key exclusion criteria
1.Patients with severe ulcerative colitis
2.Patients concomitant with severe infection, heart failure, hepatic disorder, pulmonary disease, or CNS disease
3.Pregnant woman
4.Patients who did not agree with this study
5.Patients that physician determined inappropriate
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nakase |
Organization
Kyoto Univeristy Hospital
Division name
Gastroenterology and Hepatology
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city, Kyoto, Japan
TEL
075-751-4319
hiropy_n@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Yoshino |
Organization
Kyoto Univeristy Hospital
Division name
Gastroenterology and Hepatology
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city, Kyoto, Japan
TEL
075-751-4319
Homepage URL
tyocci@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Kyoto Univeristy Hospital
Institute
Department
Personal name
Funding Source
Organization
ADEKA Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of pharmacy, Setsunan University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Kyoto University Hospital
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city, Kyoto, Japan
Tel
0757534680
ethcom@kuhp.kyoto-u.ac.jp
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
| 2014 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S093964111830883X?via%3Dihub
Number of participants that the trial has enrolled
0
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
| 2014 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 21 | Day |
Last modified on
| 2019 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017999
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
