UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016554
Receipt number 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 10:00:25

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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 or person

Institute

Fukuoka University Central Research Institute for Endoscopy

Institute

Department

Personal name



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

Value
https://center6.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