UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000585 |
|---|---|
| Receipt number | R000000709 |
| Scientific Title | Infection of human papillomavirus and overexpression of P16 in cervical neoplasia |
| Date of disclosure of the study information | 2007/01/30 |
| Last modified on | 2011/04/12 09:20:12 |
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Basic information
Public title
Infection of human papillomavirus and overexpression of P16 in cervical neoplasia
Acronym
HPV infection and P16 overexpression
Scientific Title
Infection of human papillomavirus and overexpression of P16 in cervical neoplasia
Scientific Title:Acronym
HPV infection and P16 overexpression
Region
| Japan |
Condition
Condition
cervical neoplasia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze HPV infection and P16 overexpression
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To analyse association HPV infection and overexpression of HPV
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Cases of gynecological tumor or suspicious of cervical neoplasia
Key exclusion criteria
None
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuma Fujii |
Organization
Keio University, School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo,160-8582, Japan
TEL
0333531211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuma Fujii |
Organization
Keio University, School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo,160-8582, Japan
TEL
0333531211
Homepage URL
fujiit@a5.keio.jp
Sponsor or person
Institute
Keio University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
| 2007 | Year | 01 | Month | 30 | 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
| 2006 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 03 | Month | 01 | Day |
Other
Other related information
Int J Gynecol Cancer,16: 347-353,2006
Management information
Registered date
| 2007 | Year | 01 | Month | 28 | Day |
Last modified on
| 2011 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000709
