UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027128 |
|---|---|
| Receipt number | R000031065 |
| Scientific Title | Investigation of immune mechanism in endometriosis |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2022/03/23 14:33:13 |
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Basic information
Public title
Investigation of immune mechanism in endometriosis
Acronym
Investigation of immune mechanism in endometriosis
Scientific Title
Investigation of immune mechanism in endometriosis
Scientific Title:Acronym
Investigation of immune mechanism in endometriosis
Region
| Japan |
Condition
Condition
Endometriosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of immune mechanism in endometriosis
Basic objectives2
Others
Basic objectives -Others
Analyze the difference in the immune mechanism between patients with endometriosis and patients with non-endometriosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Immunostaining of endocervical smear
Key secondary outcomes
2. Analyze the characteristics of endometrial tissue
3. Quantitative analysis of biochemical substance in ascites
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
| 12 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Patients who are underwent surgery for gynecological disease.
2.Patients with menstrual cycle.
3.Patients who are well informed and consented to participate this study.
Key exclusion criteria
1.Patients who suspected with gynecological malignant disease.
2.Patients with pregnant or the possibility of pregnancy.
3.Patients who are considered inadequate to participate this study by investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Murakami |
Organization
Shiga University of Medical Science
Division name
Department of Obstetrics and Gynecology
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
077-548-2111
tm@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Murakami |
Organization
Shiga University of Medical Science
Division name
Department of Obstetrics and Gynecology
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
077-548-2111
Homepage URL
tm@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
Tel
077-548-3576
hqrec@belle.shiga-med.ac.jp
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
| 2017 | Year | 06 | Month | 01 | 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
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 22 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 22 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 22 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 22 | Day |
Other
Other related information
Study design is prospective study.
Patients who are performed surgery against gynecological disease, classified into the endometriosis or the control group (without endometriosis).
All patients underwent endocervical brushing and biopsy of endometrium and suctioning of ascites during surgery. We analy immune mechanism in both group.
Management information
Registered date
| 2017 | Year | 04 | Month | 25 | Day |
Last modified on
| 2022 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031065
