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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007816
Receipt No. R000009212
Scientific Title Clinical study to detect micrometastasis of gynecologic malignancies using intraoperative sentinel lymph node investigation system
Date of disclosure of the study information 2012/05/01
Last modified on 2018/08/11

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Basic information
Public title Clinical study to detect micrometastasis of gynecologic malignancies using intraoperative sentinel lymph node investigation system
Acronym Clinical study on sentinel lymphnode in gynecologic malignancies
Scientific Title Clinical study to detect micrometastasis of gynecologic malignancies using intraoperative sentinel lymph node investigation system
Scientific Title:Acronym 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
1st name
Middle name
Last name Masaki Mandai
Organization Kyoto University Graduate School of Medicine
Division name Gynecology and Obstetrics
Zip code
Address 54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto
TEL 0757513269
Email babatsu@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsukasa Baba
Organization Kyoto University Graduate School of Medicine
Division name Gynecology and Obstetrics
Zip code
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)

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
2012 Year 05 Month 01 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 Enrolling by invitation
Date of protocol fixation
2012 Year 04 Month 23 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000009212

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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