UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	tm@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031065