UMIN-CTR Clinical Trial

Basic information
Public title	A Japanese survey of gynecological malignant disease in pregnancy
Acronym	A Japanese survey of gynecological malignant disease in pregnancy
Scientific Title	A Japanese survey of gynecological malignant disease in pregnancy
Scientific Title:Acronym	A Japanese survey of gynecological malignant disease in pregnancy
Region	Japan

Condition
Condition	Cervical and ovarian cancer in pregnancy
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to survey gynecological malignant disease occurring during pregnancy in Japan.
Basic objectives2	Others
Basic objectives -Others	Epidemiologic survey
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	A Japanese survey of cervical and ovarian cancers in pregnancy
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Between January 2012 and December 2017, the patients who had diagnosed as cervical cancer or ovarian cancer in pregnancy. Border line tumor of ovarian malignancy.
Key exclusion criteria	CIN 3 in the uterine cervix
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Masaki Middle name Last name Mandai
Organization	Kyoto University
Division name	Department of Obstetrics and Gynecology
Zip code	6068507
Address	Shogoin Sakyo-ku, Kyoto, Japan
TEL	0757513269
Email	mandai@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Kondo Middle name Last name Eiji
Organization	Mie University School of Medicine
Division name	Department of Obstetrics and Gynecology
Zip code	5148507
Address	2-174, Edobashi, Tsu-city, Mie, Japan
TEL	059-232-1111
Homepage URL
Email	eijikon@clin.medic.mie-u.ac.jp

Sponsor
Institute	Japan Society of Obstetrics and Gynecology Committee on Gynecologic Oncology
Institute
Department

Funding Source
Organization	Japan Society of Obstetrics and Gynecology Committee on Gynecologic Oncology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Mie University School of Medicine
Address	2-174, Edobashi, Tsu-city, Mie, Japan
Tel	0592321111
Email	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	2018 Year 11 Month 01 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	Enrolling by invitation
Date of protocol fixation	2018 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observational research

Management information
Registered date	2018 Year 11 Month 01 Day
Last modified on	2019 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039605