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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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 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


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

Value
https://center6.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