UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study of detection of uteri cervical cancers in patients who were diagnosised more than class III by cancer screenig.Magnifying Endoscopy with NBI (ME-NBI) VS Colposcopy VS ME-NBI+Colposcopy
Title of the study (Brief title)	Comparative study of detection of uteri cervical cancers in patients who were diagnosised more than class III by cancer screenig.Magnifying Endoscopy with NBI (ME-NBI) VS Colposcopy VS ME-NBI+Colposcopy
Region	Japan

Condition
Condition	Uteri cervical cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	dectation of uteri cervical cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Compare detection rate of ME-NBI with colposcopy in uteri cervical cancer
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 ME-NBI once to the patients who were diagnosed more than class III
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 were diagnosed class III
Key exclusion criteria	The patients who have undergone medical treatment of uteri cervical cancer
Target sample size	80

Research contact person
Name of lead principal investigator	Kunihisa Uchita
Organization	Kochi Redcross Hospital
Division name	Gastroenterology
Address	Shinhonmachi 2-13-51 Kochi city
TEL	088-822-1201
Email	ucchy31@yahoo.co.jp

Public contact
Name of contact person	Kunihisa Uchita
Organization	Kochi Redcross Hospital
Division name	Gastroenterology
Address	Shinhonmachi 2-13-51
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
Name of secondary funｄer(s)

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 20 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 02 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 20 Day
Last modified on	2019 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024358