UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039455 |
|---|---|
| Receipt number | R000044987 |
| Scientific Title | Laparoscopic surgical staging for early ovarian cancer |
| Date of disclosure of the study information | 2020/02/11 |
| Last modified on | 2023/08/15 09:05:24 |
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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
| Obstetrics 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
complications (lymphocyst, edmea, lymphangitis, ileus, DVT)
recurrence rate
QOL (EORTC QLQ C-30)
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
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
eijikon@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University, Graduate School of Medicine
Institute
Department
Personal name
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
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
| 2025 | 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
| 2023 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044987
