UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039455
Receipt number R000044987
Scientific Title Laparoscopic surgical staging for early ovarian cancer
Date of disclosure of the study information 2020/02/11
Last modified on 2023/08/15 09:05:24

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Basic information

Public title

Laparoscopic surgical staging for early ovarian cancer

Acronym

Laparoscopic surgical staging for early ovarian cancer

Scientific Title

Laparoscopic surgical staging for early ovarian cancer

Scientific Title:Acronym

Laparoscopic surgical staging for early ovarian cancer

Region

Japan


Condition

Condition

early ovarian cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The safety and efficacy for laparoscopic surgical staging for early ovarian cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The safety and efficacy for laparoscopic surgical staging for early ovarian cancer

Key secondary outcomes

complications (lymphocyst, edmea, lymphangitis, ileus, DVT)
recurrence rate
QOL (EORTC QLQ C-30)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Laparoscopic surgical staging for early ovarian cancer

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

25 years-old <=

Age-upper limit

75 years-old >=

Gender

Female

Key inclusion criteria

The minimally invasive approach can be considered for restaging surgery in cases, pathologic examination showed HGSC, clear cell carcinoma, mucinous carcinoma and endometrioid carcinoma when the initial ovarian tumour has been removed and there is no risk of rupture of the ovarian lesion under 10cm

Key exclusion criteria

extreamly obesity
severe endometriosis
large uterine fibroid

Target sample size

10


Research contact person

Name of lead principal investigator

1st name EIJI
Middle name
Last name KONDO

Organization

Mie University, Graduate School of Medicine

Division name

Obstetrics and Gynecology

Zip code

5148507

Address

2-174 Edobashi, Tsu, Mie Japan

TEL

+81592321111

Email

eijikon@clin.medic.mie-u.ac.jp


Public contact

Name of contact person

1st name Eiji
Middle name
Last name Kondo

Organization

Mie University, Graduate School of Medicine

Division name

Obstetrics and Gynecology

Zip code

5148507

Address

2-174 Edobashi, Tsu, Mie Japan

TEL

+81-59-232-1111

Homepage URL


Email

eijikon@clin.medic.mie-u.ac.jp


Sponsor or person

Institute

Mie University, Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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

Mie University, Graduate School of Medicine

Address

2-174 Edobashi, Tsu, Mie Japan

Tel

+81-59-232-1111

Email

eijikon@clin.medic.mie-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



Other administrative information

Date of disclosure of the study information

2020 Year 02 Month 11 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

2017 Year 02 Month 10 Day

Date of IRB

2017 Year 07 Month 04 Day

Anticipated trial start date

2017 Year 07 Month 04 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 02 Month 11 Day

Last modified on

2023 Year 08 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044987


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name