UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030125 |
|---|---|
| Receipt number | R000034396 |
| Scientific Title | Most effective cutting in pathological examination of endoscopic resected specimen with early gastrointestinal carcinoma |
| Date of disclosure of the study information | 2017/11/27 |
| Last modified on | 2025/12/03 17:23:44 |
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Basic information
Public title
Most effective cutting in pathological examination of endoscopic resected specimen with early gastrointestinal carcinoma
Acronym
Most effective cutting in pathological examination of endoscopic resected specimen with early gastrointestinal carcinoma
Scientific Title
Most effective cutting in pathological examination of endoscopic resected specimen with early gastrointestinal carcinoma
Scientific Title:Acronym
Most effective cutting in pathological examination of endoscopic resected specimen with early gastrointestinal carcinoma
Region
| Japan |
Condition
Condition
esophageal cancer, gastric cancer, colon cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify effective cutting in pathological examination of endoscopic resected specimen with early gastrointestinal carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of pathological evaluating twice slices of the endoscopically resected gastrointestinal specimen with early carcinoma compared with conventional pathologic diagnosis
Key secondary outcomes
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
We make original slices of the specimen into twice sections by deeper cutting and evaluated them.
We diagnose pathologically all sections of twice slices and compare with the original pathologic diagnosis.
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
We use the specimens which were resected by endoscopic treatment at our hospital more than 5 years ago.
Key exclusion criteria
Adenoma
Carcinoid
SM massive cancer
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Kumei |
Organization
University of Occupational and Environmental Health
Division name
The third Department of Internal Medicine
Zip code
8078556
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka
TEL
093-603-1611
shkumei@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Kumei |
Organization
University of Occupational and Environmental Health
Division name
The third Department of Internal Medicine
Zip code
8078556
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka
TEL
093-603-1611
Homepage URL
shkumei@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
University of Occupational and Environmental Health
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka
Tel
0936031611
daigakukanri@mbox.pub.uoeh-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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 27 | Day |
Last modified on
| 2025 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034396
