UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	ucchy31@yahoo.co.jp

Sponsor
Institute	Kochi Redcross Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024389