UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034738 |
|---|---|
| Receipt number | R000039605 |
| Scientific Title | A Japanese survey of gynecological malignant disease in pregnancy |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2019/11/30 10:40:47 |
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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
| Obstetrics 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
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
eijikon@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Japan Society of Obstetrics and Gynecology Committee on Gynecologic Oncology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039605
