UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Sentinel Lymph Node Biopsy for Uterine Cancer
Title of the study (Brief title)	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
Name of lead principal investigator	Masahide Ohmichi
Organization	Osaka Medical College
Division name	Department of Obstetrics and Gynecology
Address	2-7, Daigaku-machi, Takatsuki, Osaka 569-8686, Japan
TEL	072-683-1221
Email	m-ohmichi@osaka-med.ac.jp

Public contact
Name of contact person	Tomohito Tanaka
Organization	Osaka Medical College
Division name	Department of Obstetrics and Gynecology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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