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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007501
Receipt No. 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

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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
Obsterics 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
Email 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
Email emiyagi@med.yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008743

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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