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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043870
Receipt No. 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

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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
Obsterics 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
Email 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
Email yshoburu@iuhw.ac.jp

Sponsor
Institute International University of Health and Welfare
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050082

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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