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

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 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

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

Value
https://center6.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