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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014517
Receipt No. R000016886
Scientific Title The study of the effect of laser treatment for condyloma acuminatum during pregnancy on vertical transmission of the human papilloma virus
Date of disclosure of the study information 2014/07/09
Last modified on 2017/07/18

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Basic information
Public title The study of the effect of laser treatment for condyloma acuminatum during pregnancy on vertical transmission of the human papilloma virus
Acronym The study of the effect of laser treatment for condyloma acuminatum during pregnancy on vertical transmission of the human papilloma virus
Scientific Title The study of the effect of laser treatment for condyloma acuminatum during pregnancy on vertical transmission of the human papilloma virus
Scientific Title:Acronym The study of the effect of laser treatment for condyloma acuminatum during pregnancy on vertical transmission of the human papilloma virus
Region
Japan

Condition
Condition Patients with condyloma acuminatum receiving the laser treatment during pregnancy from April 1st 2001 to March 31st 2014
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the relationship between the vertical transmission of human papilloma virus type 6 or 11 and the occurrence of JORRP
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safety and efficacy
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 All condyloma acuminatum patients who received the laser treatment during pregnancy from April 1st 2001 to March 31st 2014
Key exclusion criteria None
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kei Kawana
Organization The University of Tokyo Hospital
Division name Department of Obstetrics and Gynecology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411(ext.33407)
Email kkawana-tky@umin.org

Public contact
Name of contact person
1st name
Middle name
Last name Kei Kawana
Organization The University of Tokyo Hospital
Division name Department of Obstetrics and Gynecology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411(ext.33407)
Homepage URL
Email kkawana-tky@umin.org

Sponsor
Institute The University of Tokyo Hospital
Department of Obstetrics and Gynecology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 09 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 Completed
Date of protocol fixation
2014 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information JORRP : Juvenile-onset recurrent respiratory papillomatosis
HPV:Human papilloma virus
We are going to collect the data in the medical records, for example, HPV genotyping of the infant. Those data will be processed according to the terms of privacy policy. If you do not want us to use your data, could you indicate non-concurrence to us until August 31st 2014.

Management information
Registered date
2014 Year 07 Month 09 Day
Last modified on
2017 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016886

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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