UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A cohort study of the target protein as a novel follow-up tumor marker for patients with ovarian clear cell carcinoma after surgery
Title of the study (Brief title)	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	Etsuko Miyagi
Organization	Yokohama City University
Division name	Department of Obstetrics and Gynecology
Address	3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2800
Email	emiygi@yokohama-cu.ac.jp

Public contact
Name of contact person	Ruiz Yokota Naho
Organization	Yokohama City University
Division name	Department of Obstetrics and Gynecology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028249