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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022746
Receipt No. R000026208
Scientific Title A clinical trial of laparoscopy for endometrial cancer(included para-aortic lymphadenectomy).
Date of disclosure of the study information 2016/07/01
Last modified on 2019/07/27

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Basic information
Public title A clinical trial of laparoscopy for endometrial cancer(included para-aortic lymphadenectomy).
Acronym A clinical trial of laparoscopy for endometrial cancer(included para-aortic lymphadenectomy).
Scientific Title A clinical trial of laparoscopy for endometrial cancer(included para-aortic lymphadenectomy).
Scientific Title:Acronym A clinical trial of laparoscopy for endometrial cancer(included para-aortic lymphadenectomy).
Region
Japan

Condition
Condition endometrial cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility, safety and oncological outcome of laparoscopic surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of resected specimen
3 yr disease free survival
Key secondary outcomes Disease free survival
3,5yr survival
operation time
blood loss
transfusion rate
intra-postoperative complication
post operative quality of life compared with the laparotomy

Base
Study type Interventional

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

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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria endometrial cancer stage I, II
Key exclusion criteria 1) huge leiomyoma or adenomyosis
2) severe comorbidity
3) performance status 3.4
4) patients judged inappropriate for this study by the physician
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Aoki
Organization Keio University Scool of Medicine
Division name Obstetrics and Gynecology
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan
TEL 03-3353-1211
Email shigenorih1974@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigenori Hayashi
Organization Keio University Scool of Medicine
Division name Obstetrics and Gynecology
Zip code
Address Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email shigenorih1974@keio.jp

Sponsor
Institute Keio University Scool of Medicine
Institute
Department

Funding Source
Organization Without relevance
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2016 Year 07 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 Open public recruiting
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
2016 Year 07 Month 29 Day
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2026 Year 05 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
2016 Year 06 Month 15 Day
Last modified on
2019 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026208

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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