UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study to detect micrometastasis of gynecologic malignancies using intraoperative sentinel lymph node investigation system
Title of the study (Brief title)	Clinical study on sentinel lymphnode in gynecologic malignancies
Region	Japan

Condition
Condition	gynecologic malignancies (cervical cancer, endometrial cancer, and vulvar cancer)
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine the validity of sentinel lymph node detection system in the treatment of gynecologic malignancies
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Histopathologic diagnosis of dissected lymph nodes, positive rate of sentinel lymph nodes, and validity of dissection range
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	Prevention
Type of intervention	Maneuver
Interventions/Control_1	99mTc labeled phytic acid and patent-blue dye is injected around the lesion one day before surgery and just prior to operation, respectively. Intraoperatively, colored sentinel lymph nodes (SLN) are also identified with RI-detection device. Systematic lymphadenectomy is performed to confirm tumor metastasis in all lymph nodes including SLN by histological investigation.
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	cervical cancer stage Ia-IIb vulvar cancer stage Ia-II endometrial cancer stage Ia-II
Key exclusion criteria	Those who cannot be afforeded to standard therapy
Target sample size	150

Research contact person
Name of lead principal investigator	Masaki Mandai
Organization	Kyoto University Graduate School of Medicine
Division name	Gynecology and Obstetrics
Address	54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
TEL	0757513269
Email	babatsu@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Tsukasa Baba
Organization	Kyoto University Graduate School of Medicine
Division name	Gynecology and Obstetrics
Address	54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
TEL	0757513269
Homepage URL
Email	babatsu@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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	2012 Year 05 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 04 Month 23 Day
Anticipated trial start date	2012 Year 05 Month 01 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	2012 Year 04 Month 23 Day
Last modified on	2018 Year 08 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009212