UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Differential diagnosis of intraligamentous leiomyomas from subserosal leiomyomas using magnetic resonance imaging
Title of the study (Brief title)	MRI diagnosis of uterine leiomyomas
Region	Japan

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

Objectives
Narrative objectives1	Differential diagnosis for intraligamentous uterine leiomyomas from subserosal leiomyomas
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Positions of ovary in comparison with main leiomyoma nod in MRI
Key secondary outcomes

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	18 years-old <=
Age-upper limit	50 years-old >=
Gender	Female
Key inclusion criteria	Uterine leiomyomas who underwent surgery
Key exclusion criteria	Maximum leiomyoma size: less than 5cm
Target sample size	150

Research contact person
Name of lead principal investigator	Maki Goto
Organization	Nagoya University Hospital
Division name	Obstetrics and Gynecolgoy
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-744-2261
Email	akiwase@med.nagoya-u.ac.jp

Public contact
Name of contact person	Akira Iwase
Organization	Nagoya University Hospital
Division name	Obstetrics and Gynecology
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-744-2261
Homepage URL
Email	akiwase@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Nagoya University
Organization
Division
Category of Funding Organization	Other
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	2017 Year 02 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 12 Month 06 Day
Anticipated trial start date	2016 Year 12 Month 07 Day
Last follow-up date	2017 Year 01 Month 15 Day
Date of closure to data entry	2017 Year 01 Month 15 Day
Date trial data considered complete	2017 Year 01 Month 15 Day
Date analysis concluded	2017 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We detect the positions of ovaries and main leiomyom nods using preoperative MRI and classify the findings according to the relative position of ovaries compared with the position of leiomyomas. We analyze if this classification is useful for differential diagnosis for intraligamentous leiomyomas from subserosal leiomyomas.

Management information
Registered date	2016 Year 12 Month 01 Day
Last modified on	2017 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028870