UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020517 |
|---|---|
| Receipt number | R000023688 |
| Scientific Title | Efficacy of cytometry for diagnosis of endometrial cancer |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2017/06/05 09:17:07 |
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Basic information
Public title
Efficacy of cytometry for diagnosis of endometrial cancer
Acronym
Efficacy of cytometry for diagnosis of endometrial cancer
Scientific Title
Efficacy of cytometry for diagnosis of endometrial cancer
Scientific Title:Acronym
Efficacy of cytometry for diagnosis of endometrial cancer
Region
| Japan |
Condition
Condition
endometorial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a new objective indicators that improve diagnostic accuracy of endometrial cytology.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
sensitivity and specificity of cytometry for endometrial cytology
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
people who needs peritoneal cytology
Key exclusion criteria
under 20 yo, lack of consent capacity
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tokunaga Hideki |
Organization
Tohoku University
Division name
Gynecology
Zip code
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 | |
| Middle name | |
| Last name | Tokunaga Hideki |
Organization
Tohoku University
Division name
Gynecology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7254
Homepage URL
tokunagahideki@med.tohoku.ac.jp
Sponsor or person
Institute
Dept. of gynecology, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
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
| 2016 | Year | 03 | 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
There were no significant finding.
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
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | 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
Study Design: cohort study
Subject of recruitment method: patients need cytologic diagnosis of endometrium
Recruitment period: March-April/2016
Item measure: CPIx, CPIx
Management information
Registered date
| 2016 | Year | 01 | Month | 10 | Day |
Last modified on
| 2017 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023688
