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 |
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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
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
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
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
