UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034969
Receipt No. R000038886
Scientific Title The prospective multicentre cohort study about benign and malignant discrimination of chocolate cyst using MRI R2 value.
Date of disclosure of the study information 2018/11/21
Last modified on 2019/05/31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The prospective multicentre cohort study about benign and malignant discrimination of chocolate cyst using MRI R2 value.
Acronym MRS multicentre study
Scientific Title The prospective multicentre cohort study about benign and malignant discrimination of chocolate cyst using MRI R2 value.
Scientific Title:Acronym MRS multicentre study
Region
Japan

Condition
Condition Epithelial ovarian tumor
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of MRI R2 value to differentiate malignant ovarian epithelial tumor from benign.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Reevalutation of R2 cut-off value(endometriosis associated ovarian cancer vs endometriosis).
Key secondary outcomes 2. Evaluation of R2 value in non endometriosis associated ovarian cancer.
3. Variation in R2 value at malignant transformation.
4. Evaluation of R2 value in benign ovarian tumor (except for chocolate cyst).

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 After the conduction of MRI for ovarian tumor, to compare its R2 value and pathological outcomes as endometriosis associated ovarian cancer, non endometriosis associated ovarian cancer, endometriosis and benign ovarian tumor.
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 Epithelial ovarian tumor
Key exclusion criteria 1. Metastatic ovarian tumor
2. Inadequate patient decided by researcher
3. Less than 5cm of tumor long diameter
4. Distinctive mucinous cyst adenoma or dermoid cyst
5. Unbearable to undergo MRI(claustrophobia
etc. )
6. Inadequate patient having mental manifestation or psychiatric disorder
7. Unable to indicate one's intention
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Kawahara
Organization Nara Medical University
Division name Department of Obstetrics and gynecology
Zip code 643-8521
Address 840 Shijo-cho, Kashihara 634-8522, Japan
TEL 0744-22-3051(ext.6336)
Email naoki35@naramed-u.ac.jp

Public contact
Name of contact person
1st name Naoki
Middle name
Last name Kawahara
Organization Nara Medical University
Division name Department of Obstetrics and gynecology
Zip code 634-8521
Address 840 Shijo-cho, Kashihara 634-8522, Japan
TEL 0744-22-3051(ext.6336)
Homepage URL
Email naoki35@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor The Jikei University
Juntendo University Urayasu Hospital
Tokyo Medical University
The Jikei University Kashiwa Hospital
Teikyo University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nara Medical University
Address 840 Shijo-cho, Kashihara 634-8522, Japan
Tel 0744-22-3051
Email ino-rinri@naramed-u.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 ・東京慈恵会医科大学(東京都)
・順天堂大学医学部附属浦安病院(千葉県)
・東京医科大学(東京都)
・東京慈恵会医科大学附属柏病院(千葉県)
・帝京大学(東京都)
・公立大学法人 奈良県立医科大学(奈良県)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 21 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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 21 Day
Last modified on
2019 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038886

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.