UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023225 |
|---|---|
| Receipt number | R000026767 |
| Scientific Title | A retrospective study of impact of excised lymph node size on lymph node metastasis and prognosis in ovarian cancer |
| Date of disclosure of the study information | 2016/07/19 |
| Last modified on | 2018/01/23 22:16:57 |
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Basic information
Public title
A retrospective study of impact of excised lymph node size on lymph node metastasis and prognosis in ovarian cancer
Acronym
A retrospective study of impact of excised lymph node size on lymph node metastasis and prognosis in ovarian cancer
Scientific Title
A retrospective study of impact of excised lymph node size on lymph node metastasis and prognosis in ovarian cancer
Scientific Title:Acronym
A retrospective study of impact of excised lymph node size on lymph node metastasis and prognosis in ovarian cancer
Region
| Japan |
Condition
Condition
ovarian, fallopian tube, peritoneal cancer
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1) Whether new FIGO classification for ovarian, fallopian tube, and peritoneal cancer(2014) reflect the prognosis better than FIGO classification (1988) or not. 2) Whether size of metastatic lymph nodes and size of metastatic foci of lymph nodes has correlate with prognosis or no.
Basic objectives2
Others
Basic objectives -Others
1)The correlation FIGO2014 classification for prognosis. 2)Lymph node size and metastasis. 3)Size of lymph node and foci of metastasis has correlated with prognosis or no.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1)The correlation FIGO2014 classification for prognosis.
Key secondary outcomes
2)Lymph node size and metastasis. 3)Size of lymph node and foci of metastasis has correlated with prognosis or no.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
none
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
ovarian, fallopian, peritoneal cancer
Key exclusion criteria
metastatic cancer
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Itani |
Organization
Nara Prefecture General Medical Center
Division name
Ob & Gyn
Zip code
Address
1 30 1 Hiramatsu Nararashi Nara JAPAN
TEL
0742-46-6001
yitani@nara-hp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Itani |
Organization
Nara Prefecture General Medical Center
Division name
Ob & Gyn
Zip code
Address
1 30 1Hiramatsu Nrarashi Nara JAPAN
TEL
0742-46-6001
Homepage URL
http://www.nara-hp.jp/
kennara@nara-hp.jp
Sponsor or person
Institute
Nara Prefecture General Medical Center
Institute
Department
Personal name
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
奈良県総合医療センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 19 | Day |
Related information
URL releasing protocol
http://www.nara-hp.jp/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
not creected
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 07 | Month | 19 | Day |
Last modified on
| 2018 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026767
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
