UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012116 |
|---|---|
| Receipt number | 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 00:14:03 |
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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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014168
