UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of novel diagnostic markers for epithelial ovarian cancer
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Etsuko Miyagi
Organization	Yokohama City University Hospital
Division name	Department of Obstetrics & Gynecology
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	Etsuko Miyagi
Organization	Yokohama City University Hospital
Division name	Department of Obstetrics & Gynecology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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