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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009879
Receipt No. R000011577
Scientific Title An evaluation of colorectal tumors through false-negative fecal immunochemical testing in a referral hospital
Date of disclosure of the study information 2013/01/27
Last modified on 2019/08/15

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Basic information
Public title An evaluation of colorectal tumors through false-negative fecal immunochemical testing in a referral hospital
Acronym An evaluation of colorectal tumors through false-negative fecal immunochemical testing in a referral hospital
Scientific Title An evaluation of colorectal tumors through false-negative fecal immunochemical testing in a referral hospital
Scientific Title:Acronym An evaluation of colorectal tumors through false-negative fecal immunochemical testing in a referral hospital
Region
Japan

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

Objectives
Narrative objectives1 To clarify the endoscopic features of CRCs with false-negative fecal immunochemical test (FIT).
Basic objectives2 Others
Basic objectives -Others To evaluate the characteristics of FIT-negative colorectal cancers against FIT-positive ones.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes diameter, morphology, invation depth and presence of lymph node metastases of the colorectal cancer
Key secondary outcomes age, gender, prevalence rate, rate of symptomatic examinees, rate of invasive cancer of colorectal tumor

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 The FIT-negative examinee
Interventions/Control_2 The FIT-positive examinee
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 xaminees who are consulted for the pourpose of colonoscopy.
2.Signed informed consent forms are obtained by the examinees.
Key exclusion criteria 1.The examinees who are with serious medical condition by any disease.
2.Subjects whose eligibility for this trial is not appropriate by other reasons.
3.Evidence of increased risk in carrying colonoscopy.
Target sample size 1400

Research contact person
Name of lead principal investigator
1st name Kunihiko
Middle name
Last name Kunihiko Wakamura
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code 224-8503
Address Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama, 224-8503, Japan
TEL 045(949)7000
Email wakamura92@hkg.odn.ne.jp

Public contact
Name of contact person
1st name Kunihiko
Middle name
Last name Wakamura
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code 224-8503
Address Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama, 224-503, Japan
TEL 045(949)7000
Homepage URL
Email wakamura92@hkg.odn.ne.jp

Sponsor
Institute Digestive Disease Center , Showa University Northern Yokohama Hospital
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional review board, Showa University Northern Yokohama Hospital
Address Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama, 224-503, Japan
Tel 045-949-7175
Email irb02syh@ofc.showa-u.ac.jp

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 昭和大学横浜市北部病院消化器センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 27 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 1592
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 No longer recruiting
Date of protocol fixation
2007 Year 01 Month 01 Day
Date of IRB
2006 Year 12 Month 12 Day
Anticipated trial start date
2007 Year 01 Month 01 Day
Last follow-up date
2020 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 27 Day
Last modified on
2019 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011577

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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