UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of miRNA in blood for development of diagnostic biomarkers for endometriosis
Title of the study (Brief title)	Analysis of miRNA in blood for development of diagnostic biomarkers for endometriosis
Region	Japan

Condition
Condition	Endometriosis
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To measure miRNAs in blood collected from patients of benign gynecological diseases other than endometriosis who will undergo laparoscopic surgery. The results will be analyzed in comparison with those from endometriosis patients separately obtained from another clinical study.
Basic objectives2	Others
Basic objectives -Others	Development of less invasive diagnostic biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Concentration of miRNAs in blood
Key secondary outcomes	CA-125, CA19-9

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	Not applicable
Gender	Female
Key inclusion criteria	1. Subject is able before sample collection to date and sign the informed consent form 2. Subject is a premenopausal woman 3. Subject is scheduled prior to consent being sought to have a laparoscopy because of benign gynecological disease (such as uterine myoma) requiring surgery 4. Subject is 20 years or older at the time of consent 5. Subject is at the time of consent judged by the responsible study doctor or another physician assigned to this study not to be suffering from endometriosis
Key exclusion criteria	none
Target sample size	200

Research contact person
Name of lead principal investigator	Mari Kitade MD
Organization	Juntendo University Hospital
Division name	Department of Obstetrics and Gynecology
Address	Hongo 3-1-3, Bunkyo-ku, Tokyo 113-8431, Japan
TEL	03-3813-3111
Email	kitade@juntendo.ac.jp

Public contact
Name of contact person	Mari Kitade MD
Organization	Juntendo University Hospital
Division name	Department of Obstetrics and Gynecology
Address	Hongo 3-1-3, Bunkyo-ku, Tokyo 113-8431, Japan
TEL	03-3813-3111
Homepage URL
Email	kitade@juntendo.ac.jp

Sponsor
Institute	Juntendo University Hospital, Department of Obstetrics and Gynecology
Institute
Department

Funding Source
Organization	Takeda Pharmaceutical Company Limited
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	2012 Year 11 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 02 Day
Anticipated trial start date	2013 Year 02 Month 26 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	As a control group of a prospective study for development of a diagnostic method, blood will be collected from subjects who will undergo laparoscopic surgery due to benign gynecological diseases other than endometriosis and subjected to measurement of miRNA, CA-125 and CA19-9. The results will be analyzed in comparison with those from endometriosis patient group, which will be separately obtained from a clinical trial conducted by Takeda Pharmaceutical Company (TAK385/ CCT-101).

Management information
Registered date	2012 Year 10 Month 30 Day
Last modified on	2016 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010833