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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003740
Receipt No. R000004505
Scientific Title Evaluation of the efficacy of narrow band imaging with magnifying colonoscopy for the diagnosis of dysplasia.
Date of disclosure of the study information 2010/07/01
Last modified on 2013/06/13

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Basic information
Public title Evaluation of the efficacy of narrow band imaging with magnifying colonoscopy for the diagnosis of dysplasia.
Acronym Prospective analysis of NBI-ME for colorectal dysplasia
Scientific Title Evaluation of the efficacy of narrow band imaging with magnifying colonoscopy for the diagnosis of dysplasia.
Scientific Title:Acronym Prospective analysis of NBI-ME for colorectal dysplasia
Region
Japan

Condition
Condition Colorectal neoplasm
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To estimate the efficacy of Narrow band imaging with magnifying colonoscopy (NBI-ME) for the diagnosis of dysplasia of colorectal neoplasm.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Specificity of NBI-ME in accurate decision for low grade dysplasia.
Key secondary outcomes Procedure time (insertion and observation), Diagnostic ability (sensitivity, specificity and accuracy) for high grade dysplasia, low grade dysplasia and non-neoplastic lesion using NBI-nonME and NBI-ME, Accurate clinical decision rate (resect and discard, resect and send and leave it in situ) using NBI-nonME and NBI-ME. Diagnostic accuracy according to the lesion size (<5mm, >6mm). Adverse events.

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
Device,equipment
Interventions/Control_1 Magnifying observation using magnifying endoscope.
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 Patients who are undergoing colonoscopy for positive fecal occult blood test, surveillance colonoscopy after endoscopic resection, and colonoscopic resection of colorectal neoplasms.
Key exclusion criteria 1)Patients who had previously undergone histological examination.
2)Patients with open bleeding or symptoms suspected colonic stenosis.
3)Patients with inflammatory bowel disease, familial polyposis and known colon neoplasm.
4)Patients who are receiving anticoaglant medication or having bleeding tendency.
5)Patients with severe organ failure.
6)Patients without informed consent.
7)Patients who are regarded in-eligible by the doctor who participates in this study.
Target sample size 550

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoji Takeuchi
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Gastrointestinal Oncology
Zip code
Address 1-3-3, Nakamichi, Higashinari-ku, Osaka
TEL 06-6972-1181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoji Takeuchi
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Gastrointestinal Oncology
Zip code
Address 1-3-3, Nakamichi, Higashinari-ku, Osaka
TEL 06-6972-1181
Homepage URL
Email takeuti-yo@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
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 大阪府立成人病センター(大阪府)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 01 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 Completed
Date of protocol fixation
2010 Year 06 Month 07 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2012 Year 07 Month 01 Day
Date of closure to data entry
2012 Year 08 Month 01 Day
Date trial data considered complete
2012 Year 10 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 12 Day
Last modified on
2013 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004505

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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