UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009570 |
|---|---|
| Receipt number | 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 09:39:45 |
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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
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
tamatsud@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital, Tokyo, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011231
