UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034969 |
|---|---|
| Receipt number | 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 | 2023/10/29 14:14:49 |
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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
| Obstetrics 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)
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
naoki35@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
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
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
| Delay expected |
Results Delay Reason
Restriction of medical treatment due to COVID-19 has occured.
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
| 2018 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 21 | Day |
Last modified on
| 2023 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038886
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
