UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019707
Receipt No. R000022764
Scientific Title Study of diagnostic laparoscopy for advanced ovarian cancer
Date of disclosure of the study information 2015/11/16
Last modified on 2020/05/13

* 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 Study of diagnostic laparoscopy for advanced ovarian cancer
Acronym Diagnostic laparoscopy for ovarian cancer
Scientific Title Study of diagnostic laparoscopy for advanced ovarian cancer
Scientific Title:Acronym Diagnostic laparoscopy for ovarian cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the safety and efficacy of diagnostic laparoscopy for advanced ovarian cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Time of surgery and anesthesia, blood loss, adverse events and period of time for the administration of chemotherapy
Key secondary outcomes Hospitalization,amount of pain killer after surgery and periods of time of recovery.

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 Diagnostic laparoscopy
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
70 years-old >
Gender Female
Key inclusion criteria Advanced ovarian cancer
Women who can not undergo complete surgery
Serous or endometrioid carinoma are suspected
Written informed concent
Key exclusion criteria Advanced adhesions of pelvic cavity
Advanced obesity
Physician decision
Target sample size 5

Research contact person
Name of lead principal investigator
1st name KAZU
Middle name
Last name Ueda
Organization The jikei university school of medicine
Division name Department of Obstetrics and Gynecology
Zip code 105-8471
Address 3-19-18 Nishi-shinbashi Minato-ku, Tokyo, Japan
TEL +81-3-3433-1111
Email kazu@jikei.ac.jp

Public contact
Name of contact person
1st name KAZU
Middle name
Last name Ueda
Organization The jikei university school of medicine
Division name Department of Obstetrics and Gynecology
Zip code 105-8471
Address 3-19-18 Nishi-shinbashi Minato-ku, Tokyo, Japan
TEL +81-3-3433-1111
Homepage URL
Email kazu@jikei.ac.jp

Sponsor
Institute The jikei university school of medicine
Institute
Department

Funding Source
Organization none
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 The Jikei university school of medicine
Address 3-19-18 Nishi-shinbashi Minato-ku, Tokyo, Japan
Tel +81-3-3433-1111
Email kazu@jikei.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
2015 Year 11 Month 16 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 5
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 No longer recruiting
Date of protocol fixation
2015 Year 09 Month 25 Day
Date of IRB
2015 Year 07 Month 11 Day
Anticipated trial start date
2015 Year 11 Month 16 Day
Last follow-up date
2021 Year 08 Month 20 Day
Date of closure to data entry
Date trial data considered complete
2016 Year 08 Month 20 Day
Date analysis concluded
2016 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 11 Month 09 Day
Last modified on
2020 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022764

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2016/07/19 審議結果報告書.Jikei-01.docx


Contact us.