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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009223
Receipt No. R000010833
Scientific Title Analysis of miRNA in blood for development of diagnostic biomarkers for endometriosis
Date of disclosure of the study information 2012/11/30
Last modified on 2016/11/02

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Basic information
Public title Analysis of miRNA in blood for development of diagnostic biomarkers for endometriosis
Acronym Analysis of miRNA in blood for development of diagnostic biomarkers for endometriosis
Scientific Title Analysis of miRNA in blood for development of diagnostic biomarkers for endometriosis
Scientific Title:Acronym 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
1st name
Middle name
Last name Mari Kitade MD
Organization Juntendo University Hospital
Division name Department of Obstetrics and Gynecology
Zip code
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
1st name
Middle name
Last name Mari Kitade MD
Organization Juntendo University Hospital
Division name Department of Obstetrics and Gynecology
Zip code
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)

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
2012 Year 11 Month 30 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
2012 Year 11 Month 02 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000010833

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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