UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031712 |
|---|---|
| Receipt number | R000036211 |
| Scientific Title | Usefulness of in vivo cell imaging using endoscopy for cervical and vaginal intraepithelial tumors |
| Date of disclosure of the study information | 2018/03/14 |
| Last modified on | 2020/06/18 20:04:40 |
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Basic information
Public title
Usefulness of in vivo cell imaging using endoscopy for cervical and vaginal intraepithelial tumors
Acronym
Endocytoscopic imaging of cervical and vaginal intraepithelial tumors
Scientific Title
Usefulness of in vivo cell imaging using endoscopy for cervical and vaginal intraepithelial tumors
Scientific Title:Acronym
Endocytoscopic imaging of cervical and vaginal intraepithelial tumors
Region
| Japan |
Condition
Condition
cervical and vaginal intraepithelial tumors
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of endocytoscopy for diagnosis of cervical and vaginal intraepithelial tumors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diagnostic accuracy of endocytoscopic images to histological diagnosis from biopsy
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
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Endoscopic intervention is only one day of the examination date
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
Female
Key inclusion criteria
Patients who have intraepithelial tumors of ervical and vagina
Key exclusion criteria
Patitents who have a history of allergy to methylene blue
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoko Ono |
Organization
Hokkaido University Hospital
Division name
Divison of Endoscopy
Zip code
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
TEL
0117161161
onosho@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoko Ono |
Organization
Hokkaido University Hospital
Division name
Divison of Endoscopy
Zip code
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Japan
TEL
0117161161
Homepage URL
onosho@med.hokudai.ac.jp
Sponsor or person
Institute
Divison of Endoscopy, Hokkaido University Hospital
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
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 14 | 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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 22 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 22 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 14 | Day |
Last modified on
| 2020 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036211
