UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043355 |
|---|---|
| Receipt number | R000049501 |
| Scientific Title | Evaluation of the accuracy of diagnosis by Endocytosopy in SNADET |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2023/09/19 09:59:11 |
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Basic information
Public title
Evaluation of the accuracy of diagnosis by Endocytosopy in SNADET
Acronym
Evaluation of the accuracy by Endocytosopy in SNADET
Scientific Title
Evaluation of the accuracy of diagnosis by Endocytosopy in SNADET
Scientific Title:Acronym
Evaluation of the accuracy by Endocytosopy in SNADET
Region
| Japan |
Condition
Condition
SNADET
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the diagnosis for SNADET by Endocytoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity, specificity, positive predictive value, negative predictive value, and positive predictive value of offline adenoma and cancer diagnosis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for endoscopic treatment or surgery for SNADET at our hospital
Key exclusion criteria
Cases of residual recurrence after endoscopic treatment
Patients who are allergic to methylene blue
Patients who are difficult to perform Endocyto (difficult to insert endoscope, difficult to observe, etc.) and other patients who are considered difficult to register by the doctor in charge.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Seiichiro |
| Middle name | |
| Last name | Abe |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
1040045
Address
5-1-1 Tsukiji, Chuoku, Tokyo
TEL
03-3542-2511
seabe@ncc.go.jp
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Ego |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
1040045
Address
5-1-1 Tsukiji, Chuoku, Tokyo
TEL
03-3542-2511
Homepage URL
mego@ncc.go.jp
Sponsor or person
Institute
Endoscopy Division, National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Endoscopy Division, National Cancer Center Hospital
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
Endoscopy Division, National Cancer Center Hospital
Address
5-1-1 Tsukiji, Chuoku, Tokyo
Tel
03-3542-2511
03-3542-2511
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
| 2021 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2020 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of the accuracy of diagnosis by Endocytosopy in SNADET
Management information
Registered date
| 2021 | Year | 02 | Month | 17 | Day |
Last modified on
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049501
