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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025292
Receipt No. R000029074
Scientific Title Evaluation of biomarker potential of Cystatin B for detection of ovarian cancer
Date of disclosure of the study information 2016/12/15
Last modified on 2016/12/15

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Basic information
Public title Evaluation of biomarker potential of Cystatin B for detection of ovarian cancer
Acronym Evaluation of biomarker potential of Cystatin B for detection of ovarian cancer
Scientific Title Evaluation of biomarker potential of Cystatin B for detection of ovarian cancer
Scientific Title:Acronym Evaluation of biomarker potential of Cystatin B for detection of ovarian cancer
Region
Japan

Condition
Condition Ovarian cancer, Endometriosis, Uterine fibroid
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study is to assess the utility of Cystatin B (CSTB), a secreted protein, as diagnostic marker for ovarian cancer. The primary endpoint is to assess whether CSTB is more useful to diagnose ovarian cancer and non-ovarian cancer, compared with CA125.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of the area under the curve (AUC) of Reciever Operating Characteristic Curves (ROC curves) between serum CSTB and CA125
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
40 years-old <=
Age-upper limit
60 years-old >=
Gender Female
Key inclusion criteria 1. Ovarian cancer patients newly diagnosed (all ages)
2. Endometriosis patients newly diagnosed
3. Uterine fibroid patients newly diagnosed
Key exclusion criteria 1. Previous history of any cancers
2. Multiple malignancies
3. Patients previously treated
4. Individuals who did not accept informed consent
5. Inappropriateness by doctor's judgement
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ishino Kousuke
Organization Nippon Medical School
Division name Department of Integrated Diagnostic Pathology
Zip code
Address 1-1-5, SENDAGI, BUNKYO-KU, TOKYO
TEL 03-3822-2131
Email kishino@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ishino Kousuke
Organization Nippon Medical School
Division name Department of Integrated Diagnostic Pathology
Zip code
Address 1-1-5, SENDAGI, BUNKYO-KU, TOKYO
TEL 03-3822-2131
Homepage URL
Email kishino@nms.ac.jp

Sponsor
Institute Department of Integrated Diagnostic Pathology, Nippon Medical School
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Nippon Medical School

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 12 Month 15 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 Preinitiation
Date of protocol fixation
2016 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients with ovarian cancer, endometriosis and uterine fibroid are enrolled in this study. This study aimed to assess the usefulness of serum CSTB as a diagnostic biomarker in patients with ovarian cancer.

Management information
Registered date
2016 Year 12 Month 15 Day
Last modified on
2016 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029074

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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