UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028524
Receipt No. 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

* 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
Obsterics 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
Last 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
Email m-ohmichi@osaka-med.ac.jp

Public contact
1st 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
Email gyn123@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032646

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.