UMIN-CTR Clinical Trial

Basic information
Public title	The detection of sentinel lymph nodes in surgery for uterine cancer using indocyanine green, and blue dye.
Acronym	The detection of sentinel lymph nodes in surgery for uterine cancer using indocyanine green, and blue dye.
Scientific Title	The detection of sentinel lymph nodes in surgery for uterine cancer using indocyanine green, and blue dye.
Scientific Title:Acronym	The detection of sentinel lymph nodes in surgery for uterine cancer using indocyanine green, and blue dye.
Region	Japan

Condition
Condition	cervical cancer, endometrial cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of detection of sentinel lymph nodes in surgery for uterine cancer using indocyanine green, and blue dye.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of detection for sentinel lymph nodes
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	Medicine Maneuver
Interventions/Control_1	detection of sentinel lymph nodes in 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	Not applicable
Gender	Female
Key inclusion criteria	1. Patients with stage1 cervical cancer or uterine cancer 2. The tumor of cervical cancer is under 2cm. 3. The tumor of uterine cancer is grade1 or grade2. 4. Patients who give informed consent about detection of sentinel lymph nodes in surgery
Key exclusion criteria	Patients who had taken chemotherapy or radiotherapy before surgery.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Satoru Middle name Last name Kyo
Organization	Shimane University Faculty of Medicine
Division name	Department of Obstetrics and Gynecology
Zip code	693-8501
Address	89-1 Enya-cho Izumo-shi, Shimane, Japan
TEL	0853-20-2268
Email	satoruky@med.shimane-u.ac.jp

Public contact
Name of contact person	1st name Kentaro Middle name Last name Nakayama
Organization	Shimane University Faculty of Medicine
Division name	Department of Obstetrics and Gynecology
Zip code	693-8501
Address	89-1 Enya-cho Izumo-shi, Shimane, Japan
TEL	0853-20-2268
Homepage URL
Email	kn88@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization	None
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	Bio Ethical Committee in Shimane University Hospital
Address	89-1 Enya-cho Izumo-shi, Shimane, Japan
Tel	0853-20-2259
Email	kenkyu@med.shimane-u.ac.jp

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	2019 Year 06 Month 17 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	Open public recruiting
Date of protocol fixation	2017 Year 12 Month 18 Day
Date of IRB	2018 Year 01 Month 22 Day
Anticipated trial start date	2018 Year 01 Month 22 Day
Last follow-up date	2026 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 06 Month 17 Day
Last modified on	2019 Year 06 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042259