UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024545 |
|---|---|
| Receipt number | 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 09:32:51 |
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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
| Obstetrics 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
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
nhyokota@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028249
