UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033251 |
|---|---|
| Receipt number | R000037861 |
| Scientific Title | Evaluation of the usefulness and safety of Endo-Cytoscopy-System using in vivo staining methods |
| Date of disclosure of the study information | 2018/07/10 |
| Last modified on | 2019/02/17 15:53:59 |
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Basic information
Public title
Evaluation of the usefulness and safety of Endo-Cytoscopy-System using in vivo staining methods
Acronym
Evaluation of the usefulness and safety of Endo-Cytoscopy-System using in vivo staining methods
Scientific Title
Evaluation of the usefulness and safety of Endo-Cytoscopy-System using in vivo staining methods
Scientific Title:Acronym
Evaluation of the usefulness and safety of Endo-Cytoscopy-System using in vivo staining methods
Region
| Japan |
Condition
Condition
pharyngolaryngeal epithelial tumor, epithelial tumor of digestive tract, inflammatory bowel disease
Classification by specialty
| Gastroenterology | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to evaluate the usefulness and safety of Endo-Cytoscopy-System using in vivo staining methods.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The diagnostic agreement between diagnosis by endocytoscopy and pathological diagnosis by biopsy, endoscopic resection and operation.
Key secondary outcomes
Diagnostic ability for tumor and inflammatory bowel disease by endocytoscopy (sensitivity, specificity, positive predictive value, and negative predictive value), Diagnostic ability of depth of invasion of tumor (sensitivity, specificity, accuracy, positive predictive value, and negative predictive value)
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergo an endoscopy with endocytoscopy
Key exclusion criteria
Patients who did not obtain consent
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Yamamura |
Organization
Nagoya university hospital
Division name
Department of Endoscopy
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi prefecture
TEL
0527412172
tyamamu@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaya Esaki |
Organization
Nagoya university hospital
Division name
Department of Endoscopy
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi prefecture
TEL
0527412172
Homepage URL
em6089@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Endoscopy, Nagoya university hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Endoscopy, Nagoya university 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
Address
Tel
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
| 2018 | Year | 07 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is to evaluate the usefulness and safety of Endo-Cytoscopy-System using in vivo staining methods
Management information
Registered date
| 2018 | Year | 07 | Month | 02 | Day |
Last modified on
| 2019 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037861
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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