UMIN-CTR Clinical Trial

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

Condition
Condition	Ovarian clear cell carcinoma
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We examine complementarity and subsidiarity of the target protein and CA125 measurement at the time of the follow-up from pre to post-operation.
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

Assessment
Primary outcomes	Changes in serum levels of target protein and CA125 before and after surgery(every 1-3 month)
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	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	15

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yusuke Kunimi
Organization	Kochi Health Science Center
Division name	Gynecology
Zip code
Address	2125-1, Ike, Kochi-city, Kochi-pref
TEL	088-837-3000
Email	yuusuke_kunimi@khsc.or.jp

Public contact
Name of contact person	1st name Middle name Last name Yusuke Kunimi
Organization	Kochi Health Science Center
Division name	Gynecology
Zip code
Address	2125-1, Ike, Kochi-city, Kochi-pref
TEL	088-837-3000
Homepage URL
Email	yuusuke_kunimi@khsc.or.jp

Sponsor
Institute	Kochi Health Science Center
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	高知医療センター（高知県）

Other administrative information
Date of disclosure of the study information	2017 Year 07 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	Enrolling by invitation
Date of protocol fixation	2017 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date	2017 Year 09 Month 15 Day
Last follow-up date	2018 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Samples will be analyzed accrodingly.

Management information
Registered date	2017 Year 05 Month 19 Day
Last modified on	2017 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031382

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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