UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025292 |
|---|---|
| Receipt number | 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 17:02:41 |
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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
| Obstetrics 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
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
kishino@nms.ac.jp
Sponsor or person
Institute
Department of Integrated Diagnostic Pathology, Nippon Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029074
