UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009879 |
|---|---|
| Receipt number | 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 | 2021/08/13 13:08:21 |
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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
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
wakamura92@hkg.odn.ne.jp
Sponsor or person
Institute
Digestive Disease Center , Showa University Northern Yokohama Hospital
Institute
Department
Personal name
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
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
| Delay expected |
Results Delay Reason
It takes time to analyze the results.
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
| 2021 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011577
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
