UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021142 |
|---|---|
| Receipt number | R000024389 |
| Scientific Title | Study of usefulness of NBI-ME to diagnose the margins of uteri cervical cancer and reliability of the biopsy using the endoscopic forceps used for upper GI |
| Date of disclosure of the study information | 2016/02/22 |
| Last modified on | 2020/11/18 16:59:42 |
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Basic information
Public title
Study of usefulness of NBI-ME to diagnose the margins of uteri cervical cancer and reliability of the biopsy using the endoscopic forceps used for upper GI
Acronym
Study of usefulness of NBI-ME to diagnose the margins of uteri cervical cancer and reliability of the biopsy using the endoscopic forceps used for upper GI
Scientific Title
Study of usefulness of NBI-ME to diagnose the margins of uteri cervical cancer and reliability of the biopsy using the endoscopic forceps used for upper GI
Scientific Title:Acronym
Study of usefulness of NBI-ME to diagnose the margins of uteri cervical cancer and reliability of the biopsy using the endoscopic forceps used for upper GI
Region
| Japan |
Condition
Condition
Uteri cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Accuracy of diagnosis the margin of cervical cancer using NBI-ME, and assessment of biopsy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of diagnosis the margin of cervical cancer using NBI-ME, and assessment of biopsy
Key secondary outcomes
Study the relation betweem microvasucular pattern and degree of invasion
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
| Device,equipment |
Interventions/Control_1
We will perform NBI-ME to the patients just before conization of cervical cancer.
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
The patients who will have conization
Key exclusion criteria
The patients who cannot see transformation of uterine cervix by NBI-ME
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kunihisa |
| Middle name | |
| Last name | Uchita |
Organization
Kochi Redcross Hospital
Division name
Gastroenterology
Zip code
780-8562
Address
Hadaminamimachi 1-4-63-11 Kochi city
TEL
088-822-1201
ucchy31@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kunihisa |
| Middle name | |
| Last name | Uchita |
Organization
Kochi Redcross Hospital
Division name
Gastroenterology
Zip code
780-8562
Address
Hadaminamimachi 1-4-63-11 Kochi city
TEL
088-822-1201
Homepage URL
ucchy31@yahoo.co.jp
Sponsor or person
Institute
Kochi Redcross Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Gastroenterology Faculty of Medicine,Kagawa University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kochi Redcross Hospital
Address
Hadaminamimachi 1-4-63-11 Kochi city
Tel
088-822-1201
ucchy31@yahoo.co.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
| 2016 | Year | 02 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 22 | Day |
Last modified on
| 2020 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024389
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