UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001811 |
|---|---|
| Receipt number | R000002186 |
| Scientific Title | Association of HPV infection and Other Factors for the Risk of Cervical Cancer |
| Date of disclosure of the study information | 2009/03/29 |
| Last modified on | 2016/10/19 16:23:48 |
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Basic information
Public title
Association of HPV infection and Other Factors for the Risk of Cervical Cancer
Acronym
Risk Facors for cervical cancer
Scientific Title
Association of HPV infection and Other Factors for the Risk of Cervical Cancer
Scientific Title:Acronym
Risk Facors for cervical cancer
Region
| Japan |
Condition
Condition
cervical neoplasms
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to explore the factors which is associated with cervical carcinogenesis
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
not applicable
Key secondary outcomes
not applicable
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
out-and in -patients in the gynecologic ward and clinic
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
Obstetrics and Gynecology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuma Fujii |
Organization
Keio University, School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
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(C)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Toyo University
Sekisui Medical Co
Name of secondary funder(s)
smoking research foundation
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
| 2009 | Year | 03 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2009 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 01 | Day |
Other
Other related information
to observe progoression or regression for CIN
Management information
Registered date
| 2009 | Year | 03 | Month | 29 | Day |
Last modified on
| 2016 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002186
