UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014933 |
|---|---|
| Receipt number | R000017376 |
| Scientific Title | Clinical efficacy of flexible magnifying endoscopy with narrow band imaging for cervical epithelial tumor. : the diagnosis of localization, horizontal margin and invasion degree |
| Date of disclosure of the study information | 2014/08/23 |
| Last modified on | 2023/02/28 16:54:46 |
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Basic information
Public title
Clinical efficacy of flexible magnifying endoscopy with narrow band imaging for cervical epithelial tumor.
: the diagnosis of localization, horizontal margin and invasion degree
Acronym
magnifying endoscopic examination for cervical epithelial tumor
Scientific Title
Clinical efficacy of flexible magnifying endoscopy with narrow band imaging for cervical epithelial tumor.
: the diagnosis of localization, horizontal margin and invasion degree
Scientific Title:Acronym
magnifying endoscopic examination for cervical epithelial tumor
Region
| Japan |
Condition
Condition
Cervical epithelial tumor
Classification by specialty
| Gastroenterology | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We examine the efficacy of flexible magnifying endoscopy with narrow band imaging in the diagnosis of localization, horizontal margin and invasion degree for cervical epithelial tumor.
(The diagnostic ability of flexible magnifying endoscopy versus conventional method (colposcopy) )
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
A diagnostic rate for detection, horizontal margin and invasion degree by flexible magnifying endoscopy with narrow band imaging
Key secondary outcomes
Procedure time,adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
We observe vaginal portion of cervix, cervix uteri and internal ostium of uterus by flexible magnifying endoscope.
And,target biopsy by using endoscopic biopsy forceps.
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
| 95 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients from whom informed consent was obtained.
Patients who need further examination for cervical epithelial tumor
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriko Nishiyama |
Organization
Kagawa university
Division name
Department of gastroenterology
Zip code
Address
1750-1 ooaza ikenobe miki town kida county kagawa prefecture
TEL
+81-87-891-2156
n-nori@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Nishiyama |
Organization
Kagawa university
Division name
Department of gastroenterology
Zip code
Address
1750-1 ooaza ikenobe miki town kida county kagawa prefecture
TEL
+81-87-891-2156
Homepage URL
n-nori@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Kagawa university
Organization
Division
Category of Funding Organization
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
香川大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 23 | 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
| 2014 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 23 | Day |
Last modified on
| 2023 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017376
