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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023225
Receipt No. 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

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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
Obsterics 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
Email 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/
Email kennara@nara-hp.jp

Sponsor
Institute Nara Prefecture General Medical Center
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026767

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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