UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A retrospective study of impact of excised lymph node size on lymph node metastasis and prognosis in ovarian cancer
Title of the study (Brief title)	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	Yoshio Itani
Organization	Nara Prefecture General Medical Center
Division name	Ob & Gyn
Address	1 30 1 Hiramatsu Nararashi Nara JAPAN
TEL	0742-46-6001
Email	yitani@nara-hp.jp

Public contact
Name of contact person	Yoshio Itani
Organization	Nara Prefecture General Medical Center
Division name	Ob & Gyn
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 06 Month 22 Day
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

Related information
URL releasing protocol	http://www.nara-hp.jp/
Publication of results	Unpublished
URL releasing results
Results	not creected
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/icdr_e/ctr_view.cgi?recptno=R000026767