UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024607 |
|---|---|
| Receipt number | 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 19:33:31 |
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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
| Obstetrics 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
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
gigi1juvejp@yahoo.co.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027422
