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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012116
Receipt No. R000014168
Scientific Title The comparative study of fecal immunochemical test-positive and negative colorectal tumors in opportunistic screening
Date of disclosure of the study information 2013/10/25
Last modified on 2019/08/16

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Basic information
Public title The comparative study of fecal immunochemical test-positive and negative colorectal tumors in opportunistic screening
Acronym The comparative study of FIT-positive and negative colorectal tumors in opportunistic screening
Scientific Title The comparative study of fecal immunochemical test-positive and negative colorectal tumors in opportunistic screening
Scientific Title:Acronym The comparative study of FIT-positive and negative colorectal tumors in opportunistic screening
Region
Japan

Condition
Condition colorectal tumors
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the endoscopic features of CRCs with false-negative fecal immunochemical test (FIT) in asymptomatic examinees of opportunistic screening in our hospital.
Basic objectives2 Others
Basic objectives -Others To evaluate the characteristics of FIT-negative colorectal cancers against FIT-positive ones.
Trial characteristics_1 Confirmatory
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 The examinee who recieved FIT in our oppotunistic screening.
Key exclusion criteria The examinee who did not recieve a colonoscopy in our hospital.
Target sample size 2200

Research contact person
Name of lead principal investigator
1st name Wakamura
Middle name
Last name Kunihiko Wakamura
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code 2248503
Address Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama, 224-503, Japan
TEL 0459497000
Email kudos@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Wakamura
Middle name
Last name Kunihiko Wakamura
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code 2248503
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 fjtcrc@cmed.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 10 Month 25 Day

Related information
URL releasing protocol https://www.spandidos-publications.com/10.3892/mco.2015.591
Publication of results Published

Result
URL related to results and publications https://www.spandidos-publications.com/10.3892/mco.2015.591
Number of participants that the trial has enrolled 919
Results
The iFOBT was an excellent examination as screening of colorectal tumours.
The iFOBT might overlook small, flat or depressed tumours.
Regardless of the result of iFOBT, CS for asymptomatic examinees (screening colonoscopy) might enable us to detect colorectal tumours in a curable state by the endoscopic treatment. 
Results date posted
2019 Year 08 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
From December 2001 to August 2012, a total of 919 (276 iFOBT-positive and 643 iFOBT-negative) subclinical patients in the health screening program of our hospital underwent total colonoscopy within 2 years after iFOBT. 
Participant flow
We divided the patients into an iFOBT-positive group and iFOBT-negative group and compared the total colonoscopy findings between the two groups.
Adverse events
None
Outcome measures
The incidence and characteristics of colonic cancer lesions in asymptomatic, iFOBT-negative patients who underwent opportunistic screening.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 08 Month 01 Day
Date of IRB
2011 Year 12 Month 22 Day
Anticipated trial start date
2013 Year 10 Month 28 Day
Last follow-up date
2013 Year 10 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2014 Year 12 Month 22 Day

Other
Other related information

Management information
Registered date
2013 Year 10 Month 24 Day
Last modified on
2019 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014168

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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