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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024545
Receipt No. R000028249
Scientific Title A cohort study of the target protein as a novel follow-up tumor marker for patients with ovarian clear cell carcinoma after surgery
Date of disclosure of the study information 2016/10/27
Last modified on 2017/08/09

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Basic information
Public title A cohort study of the target protein as a novel follow-up tumor marker for patients with ovarian clear cell carcinoma after surgery
Acronym A cohort study of a novel ovarian CCC tumor marker
Scientific Title A cohort study of the target protein as a novel follow-up tumor marker for patients with ovarian clear cell carcinoma after surgery
Scientific Title:Acronym A cohort study of a novel ovarian CCC tumor marker
Region
Japan

Condition
Condition Ovarian cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To validate the target protein as a follow-up tumor marker for ovarian clear cell carcinoma patients
Basic objectives2 Others
Basic objectives -Others Practical clinical use of the target protein as a novel serum tumor marker
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Changes in serum concentrations of target protein and CA125 before and after treatment
Key secondary outcomes Complementaly effects of the target protein and CA125

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
999999 years-old >=
Gender Female
Key inclusion criteria 1. Patinets whose pre-treatment serum samples are obetained.
2.Patients who submitted the documment for written informed consent
Key exclusion criteria 1. Patients who are judged as being inappropriate for this study
2. Patients during pregnancy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Etsuko Miyagi
Organization Yokohama City University
Division name Department of Obstetrics and Gynecology
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2800
Email emiygi@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ruiz Yokota Naho
Organization Yokohama City University
Division name Department of Obstetrics and Gynecology
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2800
Homepage URL
Email nhyokota@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Tosoh Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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
2016 Year 10 Month 27 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
2016 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 27 Day
Last follow-up date
2017 Year 03 Month 09 Day
Date of closure to data entry
2017 Year 08 Month 09 Day
Date trial data considered complete
2017 Year 08 Month 09 Day
Date analysis concluded
2017 Year 09 Month 30 Day

Other
Other related information Samples will be analyzed accrodingly.

Management information
Registered date
2016 Year 10 Month 24 Day
Last modified on
2017 Year 08 Month 09 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028249

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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