UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043870 |
|---|---|
| Receipt number | R000050082 |
| Scientific Title | Safety and feasibiliy on laparoscopic surgery on borderline malignancy suspected ovarian tumor. |
| Date of disclosure of the study information | 2021/04/08 |
| Last modified on | 2021/04/08 17:49:58 |
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Basic information
Public title
Safety and feasibiliy on laparoscopic surgery on borderline malignancy suspected ovarian tumor.
Acronym
Safety and feasibiliy on laparoscopic surgery on borderline malignancy suspected ovarian tumor.
Scientific Title
Safety and feasibiliy on laparoscopic surgery on borderline malignancy suspected ovarian tumor.
Scientific Title:Acronym
Safety and feasibiliy on laparoscopic surgery on borderline malignancy suspected ovarian tumor.
Region
| Japan |
Condition
Condition
borderline smalignancy suspected ovarian tumor
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the safety and feasibility of laparoscopic surgery for ovarian borderline malignancy suspected tumors on laparoscopic surgery performed at our hospital.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety(bleedin, operartion time, perioperative complications, admission days)
Key secondary outcomes
PFS, OS, recurrence site
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Patients with preoperative diagnosis of borderline malignancy of the ovary suspected between the date of research approval and December 31, 2023.
(2) Gender: Female
(3) Age: All ages 20 years and older
(4) Patients who have given consent to participate in the study
Key exclusion criteria
Preoperative diagnosis of suspected tumor invasion.
Patients with preoperative diagnosis of ovious malignancy.
Patients with significant ascites effusion
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shoburu |
| Middle name | |
| Last name | Yuichi |
Organization
International University of Health and Welfare, Mita Hospital
Division name
gynecology
Zip code
108-8329
Address
1-4-3 Mita, Minatoku, Tokyo 108-8329, Japan
TEL
0334518121
yshoburu@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Shoburu |
| Middle name | |
| Last name | Yuichi |
Organization
International University of Health and Welfare, Mita Hospital
Division name
gynecology
Zip code
108-8329
Address
1-4-3 Mita, Minatoku, Tokyo 108-8329, Japan
TEL
0334518121
Homepage URL
yshoburu@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
no cost
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
1-4-3 Mita, Minatoku, Tokyo 108-8329, Japan
Tel
0334518121
yshoburu@iuhw.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
| 2021 | Year | 04 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation items
1) Basic patient information: age, diagnosis, height, weight, complications
2) Blood tests: tumor marker values, coagulation system, WBC, Hb, Plt, CRP
3) Pathological examination: histopathological diagnosis, cytological diagnosis results
4) Imaging tests: MRI, CT, PETCT (any of them)
Management information
Registered date
| 2021 | Year | 04 | Month | 08 | Day |
Last modified on
| 2021 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050082
