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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015493
Receipt No. 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

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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
Last 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
Email hiropy_n@kuhp.kyoto-u.ac.jp

Public contact
1st 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
Email tyocci@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Kyoto Univeristy Hospital
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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