UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028524 |
|---|---|
| Receipt number | R000032646 |
| Scientific Title | Sentinel Lymph Node Biopsy for Uterine Cancer |
| Date of disclosure of the study information | 2017/08/03 |
| Last modified on | 2017/08/03 18:01:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Sentinel Lymph Node Biopsy for Uterine Cancer
Acronym
Senti-OMC
Scientific Title
Sentinel Lymph Node Biopsy for Uterine Cancer
Scientific Title:Acronym
Senti-OMC
Region
| Japan |
Condition
Condition
Uterin cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the omission of systematic pelvic lymphadenectomy with sentinel node biopsy in uterine cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
lyph node recurrence rate, progression free survival, overall survival
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
During surgery
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
| 90 | years-old | > |
Gender
Female
Key inclusion criteria
cervical cancer of stage IA, IB and IIA1 with diameter of 2cm
endometrial cancer of stage Ia1 and grade 1 or 2
Key exclusion criteria
advanced cancer
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahide Ohmichi |
Organization
Osaka Medical College
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-7, Daigaku-machi, Takatsuki, Osaka 569-8686, Japan
TEL
072-683-1221
m-ohmichi@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohito Tanaka |
Organization
Osaka Medical College
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Daigaku-machi, Takatsuki, Osaka 569-8686, Japan
TEL
072-683-1221
Homepage URL
gyn123@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 08 | Month | 03 | 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
| 2017 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 04 | 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
| 2017 | Year | 08 | Month | 03 | Day |
Last modified on
| 2017 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032646
