UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007501 |
|---|---|
| Receipt number | R000008743 |
| Scientific Title | Development of novel diagnostic markers for epithelial ovarian cancer |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2016/06/01 16:50:51 |
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Basic information
Public title
Development of novel diagnostic markers for epithelial ovarian cancer
Acronym
Development of novel diagnostic markers for epithelial ovarian cancer
Scientific Title
Development of novel diagnostic markers for epithelial ovarian cancer
Scientific Title:Acronym
Development of novel diagnostic markers for epithelial ovarian cancer
Region
| Japan |
Condition
Condition
ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We have identified several biomarker candidates that might be associated with histological types or prognosis of epithelial ovarian cancer. Here, we aim to evaluate clinical application of these markers with determination of the serum levels in patients using our established assay systems.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Accuracy in discriminating patients with ovarian cancer from patients with benign tumor
2. Specificity to the histological type of ovarian cancer
3. Relationship between their serum levels and prognosis
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
women over 20 years old
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Etsuko Miyagi |
Organization
Yokohama City University Hospital
Division name
Department of Obstetrics & Gynecology
Zip code
Address
Fukuura 3-9, Kanazawa-ku, Yokohama, Japan
TEL
+81-45-787-2800
emiyagi@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Etsuko Miyagi |
Organization
Yokohama City University Hospital
Division name
Department of Obstetrics & Gynecology
Zip code
Address
Fukuura 3-9, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2800
Homepage URL
emiyagi@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
| 2012 | Year | 04 | 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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Two hundred and sixty-eight patients were included in this study.
Management information
Registered date
| 2012 | Year | 03 | Month | 14 | Day |
Last modified on
| 2016 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008743
