UMIN-CTR Clinical Trial

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