UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective investigation of actual conditions of elderly patients with ovarian,fallopian tube,and peritoneal cancer
Title of the study (Brief title)	elderly patients with ovarian,fallopian tube,and peritoneal cancer
Region	Japan

Condition
Condition	pathologically confirmed ovarian, fallopian, peritoneal cancer
Classification by specialty	Obsterics and gynecology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Current treatment status of ovarian, fallopian, and peritoneal cancer for >65 year-old elderly patients were retrospectively investigated.
Basic objectives2	Others
Basic objectives -Others	To research the aspect clinical course of therapeutic process in elderly cancer patients more than 65 year-old by comparing younger patientsless than 65 year-old in this explorative survey .
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	feasibility for surgery, chemotherapy
Key secondary outcomes	occurence of adverse events

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 cancer, fallopian tube cancer, peritoneal cancer
Key exclusion criteria	asked to remove from the study
Target sample size	160

Research contact person
Name of lead principal investigator	Yoshio Itani
Organization	Nara Prefectural General Medical Center
Division name	Ob & Gyn
Address	1-30-1 Hiramatsu Narashi, Nara, JAPAN
TEL	0742-46-6001
Email	yitani@nara-hp.jp

Public contact
Name of contact person	Yoshio Itani
Organization	Nara Prefectural General Medical Center
Division name	Ob & Gyn
Address	1-30-1 Hiramatsu Narashi, Nara, JAPAN
TEL	0742-46-6001
Homepage URL	http://www.nara-hp.jp/
Email	yitani@nara-hp.jp

Sponsor
Institute	Nara Prefectural General Medical Center 1-30-1 Hiramatsu Narashi, Nara, JAPAN
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)	none

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(奈良県)

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	2016 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 12 Month 31 Day
Date trial data considered complete	2016 Year 12 Month 31 Day
Date analysis concluded	2018 Year 12 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	data collecting

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=R000026764