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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039455
Receipt No. R000044987
Scientific Title Laparoscopic surgical staging for early ovarian cancer
Date of disclosure of the study information 2020/02/11
Last modified on 2020/02/11

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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
Obsterics 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

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
Institute Mie University, Graduate School of Medicine
Institute
Department

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
2021 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
2020 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.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


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