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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024607
Receipt No. R000027422
Scientific Title Sentinel lymph node detection in gynecologic cancer
Date of disclosure of the study information 2016/12/01
Last modified on 2019/04/06

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Basic information
Public title Sentinel lymph node detection in gynecologic cancer
Acronym Sentinel lymph node detection in gynecologic cancer
Scientific Title Sentinel lymph node detection in gynecologic cancer
Scientific Title:Acronym Sentinel lymph node detection in gynecologic cancer
Region
Japan

Condition
Condition Endometrial cancer Cervical cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We examine detection of sentinel lymph node in endometrial cancer and cervical cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes In endometrial cancer and cervical cancer cases, we detect sentinel lymph node in pre/peri operation
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 A Day before the operation
Inject 99mTc-Phytate or 99mTc-Tin colloid to uterine cervix/uterus body

The day of the operation
Inject 1% patent blue or indocyanine green to uterine cervix/uterus body
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 Endometrial cancer clinical stage 1A-2
Cervical cancer clinical stage 1A-2B
Key exclusion criteria 1: Allergy career; 99mTc-Phytate, 99mTc-Tin colloid , 1% patent blue, indocyanine green
2: A pregnant woman, a nursing woman and the patient who may be pregnant
3: The patient whom we judged to be inappropriate as a study subject
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke Butsuhara
Organization Kansai Medical University
Division name Department of obstetrics and gynecology
Zip code
Address 2-5-1 Shin-machi Hirakata city Osaka 573-1010 Japan
TEL 0728040101
Email gigi1juvejp@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Butsuhara
Organization Kansai Medical University
Division name Department of obstetrics and gynecology
Zip code
Address 2-5-1 Shin-machi Hirakata city Osaka 573-1010 Japan
TEL 0728040101
Homepage URL
Email gigi1juvejp@yahoo.co.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization pass
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
Email

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 12 Month 01 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 Terminated
Date of protocol fixation
2016 Year 10 Month 17 Day
Date of IRB
2016 Year 11 Month 02 Day
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 28 Day
Last modified on
2019 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027422

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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