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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018023
Receipt No. R000020840
Scientific Title Detection of sentinel lymph node metastases in cervical cancer: Performance evaluation of the OSNA assay
Date of disclosure of the study information 2015/06/22
Last modified on 2018/12/25

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Basic information
Public title Detection of sentinel lymph node metastases in cervical cancer: Performance evaluation of the OSNA assay
Acronym Performance evaluation of the OSNA assay
Scientific Title Detection of sentinel lymph node metastases in cervical cancer: Performance evaluation of the OSNA assay
Scientific Title:Acronym Performance evaluation of the OSNA assay
Region
Japan

Condition
Condition Cervical cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Detection of sentinel lymph node metastases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Concordance rate between the OSNA assay and histopathological examination
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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Using OSNA assay, we perform the performance evaluation of sentinel lymph node metastatic diagnosis in cervical cancer.
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
75 years-old >=
Gender Female
Key inclusion criteria Uterine cervical cancer
Key exclusion criteria 1)lymph node metastasis and distant metastasis on magnetic resonance imaging and/or computed tomography at their preoperative evaluation
2)history of treatment of radiotherapy and/or chemotherapy
3)history of treatment of uterine adnexectomy
4)an allergic medical history of RI and/or blue dye
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hedeki Tokunaga
Organization Tohoku University Hospital
Division name gynecology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7254
Email tokunagahideki@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Okamoto
Organization Tohoku University Hospital
Division name gynecology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7254
Homepage URL
Email s-okamoto@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
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
2015 Year 06 Month 22 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
2015 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 24 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
2015 Year 06 Month 22 Day
Last modified on
2018 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020840

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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