UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009223 |
|---|---|
| Receipt number | 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 09:09:57 |
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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
| Obstetrics 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
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
kitade@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Hospital, Department of Obstetrics and Gynecology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010833
