UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005996
Receipt number R000007083
Scientific Title Molecular analysis of ACF as a colorectal precancerous lesion
Date of disclosure of the study information 2011/07/31
Last modified on 2011/07/18 13:20:29

* 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

Molecular analysis of ACF as a colorectal
precancerous lesion

Acronym

Molecular analysis of ACF

Scientific Title

Molecular analysis of ACF as a colorectal
precancerous lesion

Scientific Title:Acronym

Molecular analysis of ACF

Region

Japan


Condition

Condition

Aberrant crypt foci

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Molecular analysis of ACF and development of the molecular imaging system

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To establish a molecule imaging system of ACF

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Biopsy of ACF and normal colorectal mucosa

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

Candidate patients have to meet all the following inclusion to participate in the study

#1Patient with written informed consent is obtained

#2 Patients with at least one ACF of colorectal mucosa

Key exclusion criteria

#1 Patients with bleeding tendency
#2 Patients with Familial Adenomatous Polyposis and Hereditary Non-Polyposis Colorectal Cancer
#3Patients with known allergy to methylene blue

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuji Takayama

Organization

Department of gastroenterology and oncology institute of health biosciences
the university of tokushima graduate school

Division name

Gastoenterology

Zip code


Address

3-18-15, Kuramoto-cho, Tokushima

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Department of gastroenterology and oncology institute of health biosciences

Division name

Gastoenterology

Zip code


Address


TEL

088-633-7124

Homepage URL


Email



Sponsor or person

Institute

Department of gastroenterology and oncology institute of health biosciences
the university of tokushima graduate school

Institute

Department

Personal name



Funding Source

Organization

Olympus Corporation

Organization

Division

Category of Funding Organization

Profit organization

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

2011 Year 07 Month 31 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

Preinitiation

Date of protocol fixation

2011 Year 07 Month 31 Day

Date of IRB


Anticipated trial start date

2011 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 07 Month 18 Day

Last modified on

2011 Year 07 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007083


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name