UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000009570
Receipt No. R000011231
Scientific Title Diagnostic sensitivity analysis of the immunochemical fecal occult blood test for colorectal cancers
Date of disclosure of the study information 2013/04/01
Last modified on 2019/06/27 (Ver. 13)

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Basic information
Public title Diagnostic sensitivity analysis of the immunochemical fecal occult blood test for colorectal cancers
Acronym FIT STUDY
Scientific Title Diagnostic sensitivity analysis of the immunochemical fecal occult blood test for colorectal cancers
Scientific Title:Acronym FIT STUDY
Region
Japan

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

Objectives
Narrative objectives1 To assess diagnostic sensitivity of immunochemical fecal occult blood test for colorectal cancers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic sensitivity of immunochemical fecal occult blood test (FIT) for colorectal cancers based on the location, staging, tumor size and macroscopic types.
Key secondary outcomes False positive and negative rates of immunochemical fecal occult blood test (FIT) for colorectal cancers based on the location, staging, tumor size and macroscopic types.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Immunochemical fecal occult blood test (FIT) using OC sensor io (Eiken co)
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 Preoperative case over 20 years old who has a primary early/ advanced colorectal cancer.
Key exclusion criteria Patient who has synchronous colorectal cancers, IBD and GI cancers.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Takahisa
Middle name
Last name Matsuda
Organization National Cancer Center Hospital, Tokyo, Japan
Division name Endoscopy Division
Zip code 104-0045
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email tamatsud@ncc.go.jp

Public contact
Name of contact person
1st name Takahisa
Middle name
Last name Matsuda
Organization National Cancer Center Hospital, Tokyo, Japan
Division name Endoscopy Division
Zip code 104-0045
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email tamatsud@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital, Tokyo, Japan
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization National Cancer Center Hospital
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel 03-3542-2511
Email tamatsud@ncc.go.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 National Cancer Center Hospital, Tokyo, Japan

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 01 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 636
Results 
FIT had significantly lower sensitivity for proximal or early CRCs, even using two stool samples. The results of our findings on screening effectiveness need further study.
Results date posted
2019 Year 06 Month 27 Day
Results Delayed
Delay expected
Results Delay Reason English paper's publication has not yet been completed
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
2014 Year 03 Month 27 Day
Date of IRB
2014 Year 07 Month 22 Day
Anticipated trial start date
2014 Year 07 Month 22 Day
Last follow-up date
2016 Year 05 Month 16 Day
Date of closure to data entry
2016 Year 05 Month 16 Day
Date trial data considered complete
2016 Year 05 Month 16 Day
Date analysis concluded
2016 Year 05 Month 18 Day

Other
Other related information

Management information
Registered date
2012 Year 12 Month 18 Day
Last modified on
2019 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011231