UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016931
Receipt No. R000019655
Scientific Title A clinical trial of laparoscopy for endometrial cancer stage I, II
Date of disclosure of the study information 2015/04/01
Last modified on 2015/03/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A clinical trial of laparoscopy for endometrial cancer stage I, II
Acronym A clinical trial of laparoscopy for endometrial cancer stage I, II
Scientific Title A clinical trial of laparoscopy for endometrial cancer stage I, II
Scientific Title:Acronym A clinical trial of laparoscopy for endometrial cancer stage I, II
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
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 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Kobayashi
Organization Osaka university
Division name Obstetrics and Gynecology
Zip code
Address 2-2 Yamadaoka, Suita Osaka 565-0871
TEL 06-6879-3351
Email osakalapcx-adm@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Kobayashi
Organization Osaka university
Division name Obstetrics and Gynecology
Zip code
Address 2-2 Yamadaoka, Suita Osaka 565-0871
TEL 06-6879-3351
Homepage URL
Email osakalapcx-adm@umin.ac.jp

Sponsor
Institute Osaka university
Institute
Department

Funding Source
Organization Osaka university
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
2015 Year 04 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
2015 Year 03 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 26 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
2015 Year 03 Month 26 Day
Last modified on
2015 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019655

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.