UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016554
Receipt No. R000019211
Scientific Title Prospective trial to investigate whether white opaque substance as visualized is present in colonic hyper plastic polyps by magnifying endoscopy with narrow-band-imaging
Date of disclosure of the study information 2015/02/16
Last modified on 2015/11/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective trial to investigate whether white opaque substance as visualized is present in colonic hyper plastic polyps by magnifying endoscopy with narrow-band-imaging
Acronym White opaque substance study of colorectal hyper plastic polyp
Scientific Title Prospective trial to investigate whether white opaque substance as visualized is present in colonic hyper plastic polyps by magnifying endoscopy with narrow-band-imaging
Scientific Title:Acronym White opaque substance study of colorectal hyper plastic polyp
Region
Japan

Condition
Condition Colorectal hyperplastic polyp
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether white opaque substance, which obscure microvessels, is present in hyper plastic polyps
Basic objectives2 Others
Basic objectives -Others Histological investigation of clinical findings
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate whether white opaque substance, which obscure microvessels, is present in hyper plastic polyps
Key secondary outcomes Histological investigation of clinical findings

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

Not applicable
Gender Male and Female
Key inclusion criteria 1.The patient's age is equal to or than.
2.The patients whose ECOG performance status should be 0 or 1.
3.The patients who gave written informed consent.
Key exclusion criteria 1.Lesion pathologically diagnosed epithelial or non-epithelial tumor.
2.Patients with inflammatory bowel disease.
3.The patients with past history of colorectal surgery.
4.The patients with serious underlying disorder.
5.The lesion with erosion, ulceration or inappropriate to participate in the endoscopic observation.
6.Patients who were determined to be inappropriate to participate in the study because of severe mental disorder.
7.The patients that were determined to be inappropriate to participate in the study by the investigate.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenshi yao
Organization Fukuoka University Chikushi Hospital
Division name Depertment of Endoscopy
Zip code
Address 1-1-1 Zokumyoin Chikusjhino-city Fukuoka
TEL 092-921-1011
Email ishiharanoyoume@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi ishihara
Organization Fukuoka University Chikushi Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1-1 Zokumyoin Chikusjhino-city Fukuoka
TEL 090-2512-7479
Homepage URL
Email ishiharanoyoume@gmail.com

Sponsor
Institute Fukuoka University Central Research Institute for Endoscopy
Institute
Department

Funding Source
Organization Fukuoka University Central Research Institute for Endoscopy
Organization
Division
Category of Funding Organization Other
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
2015 Year 02 Month 16 Day

Related information
URL releasing protocol
Publication of results Partially published

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 01 Month 07 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information total case number of ninety seven

Management information
Registered date
2015 Year 02 Month 16 Day
Last modified on
2015 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019211

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.