UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association of HPV infection and Other Factors for the Risk of Cervical Cancer
Title of the study (Brief title)	Risk Facors for cervical cancer
Region	Japan

Condition
Condition	cervical neoplasms
Classification by specialty	Obsterics 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	Takuma Fujii
Organization	Keio University, School of Medicine
Division name	Obstetrics and Gynecology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email

Public contact
Name of contact person	Takuma Fujii
Organization	Keio University, School of Medicine
Division name	Obstetrics and Gynecology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	fujiit@a5.keio.jp

Sponsor
Institute	Keio University, School of Medicine
Institute
Department

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 03 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002186