UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018083 |
|---|---|
| Receipt number | R000020841 |
| Scientific Title | Detection of sentinel lymph node metastases in endometrial cancer: Performance evaluation of the OSNA assay |
| Date of disclosure of the study information | 2015/06/25 |
| Last modified on | 2024/01/04 09:08:30 |
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Basic information
Public title
Detection of sentinel lymph node metastases in endometrial cancer: Performance evaluation of the OSNA assay
Acronym
Performance evaluation of the OSNA assay
Scientific Title
Detection of sentinel lymph node metastases in endometrial cancer: Performance evaluation of the OSNA assay
Scientific Title:Acronym
Performance evaluation of the OSNA assay
Region
| Japan |
Condition
Condition
Endometrial cancer
Classification by specialty
| Obstetrics 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 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 endometrial 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
Endometrial cancer
Key exclusion criteria
1)lymph node metastasis and distant metastasis at their preoperative evaluation with magnetic resonance imaging(MRI) and/or computed tomography(CT)
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
5)ovarian metastasis and serosa invasion at their preoperative evaluation with MRI and/or CT.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Tokunaga |
Organization
Tohoku University Hospital
Division name
gynecology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7254
tokunagahideki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Okamoto |
Organization
Tohoku University Hospital
Division name
gynecology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7254
Homepage URL
s-okamoto@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
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
Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
Tel
022-717-3964
hosp-ken@bureau.tohoku.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
| 2015 | Year | 06 | Month | 25 | 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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
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 | 25 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020841
