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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028348
Receipt No. R000032451
Scientific Title Clinical trial of laparoscopic surgery for ovarian, tubal and peritoneal cancer
Date of disclosure of the study information 2017/08/01
Last modified on 2017/07/24

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Basic information
Public title Clinical trial of laparoscopic surgery for ovarian, tubal and peritoneal cancer
Acronym Lap ovary
Scientific Title Clinical trial of laparoscopic surgery for ovarian, tubal and peritoneal cancer
Scientific Title:Acronym Lap ovary
Region
Japan

Condition
Condition ovarian, tubal and peritoneal cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To survey the safety and feasibility of laparoscopic surgery for ovarian cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of resected specimen and 3 year disease free survival
Key secondary outcomes disease free survival, 3 and 5 year overall survival, operative time, intraoperative blood loss, transfusion rate, postoperative complication, post operative QOL

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 laparoscopic surgery
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

Not applicable
Gender Female
Key inclusion criteria tumor diameter below 10cm
performance status under 2
Key exclusion criteria severe comorbidity
Target sample size 25

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kobayashi Eiji
Organization Osaka University
Division name Obstetrics and Gynecology
Zip code
Address Yamadaoka 2-2, Suita
TEL 06-6879-3351
Email ekobayashi@gyne.med.osaka-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Kobayashi Eiji
Organization Osaka University
Division name Obstetrics and Gynecology
Zip code
Address Yamadaoka 2-2, Suita
TEL 06-6879-3351
Homepage URL
Email ekobayashi@gyne.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine Obstetrics and Gynecology
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine Obstetrics and Gynecology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

IRB Contact (For public release)
Organization
Address
Tel
Email

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 大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 24 Day
Last modified on
2017 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032451

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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