UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005656
Receipt number R000006665
Scientific Title preventive effect for reinfection of human papillomavirus (HPV) 16/18 against cervical intraepithelial neoplasia (CIN) 1
Date of disclosure of the study information 2011/06/30
Last modified on 2011/05/26 11:01:44

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Basic information

Public title

preventive effect for reinfection of human papillomavirus (HPV) 16/18 against cervical intraepithelial neoplasia (CIN) 1

Acronym

preventive effect for reinfection of human papillomavirus (HPV) 16/18 against cervical intraepithelial neoplasia (CIN) 1

Scientific Title

preventive effect for reinfection of human papillomavirus (HPV) 16/18 against cervical intraepithelial neoplasia (CIN) 1

Scientific Title:Acronym

preventive effect for reinfection of human papillomavirus (HPV) 16/18 against cervical intraepithelial neoplasia (CIN) 1

Region

Japan


Condition

Condition

patient with cervical intraepithelial neoplasia (CIN) 1

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

HPV typing test for female with 20s and 30s who have some experience in diagnosis of low-grade squamous intraepithelial lesion by tissue diagnosis, check the situation of infection with or without HPV 16/18, and also demonstrate the HPV vaccine efficacy to protect against 6-month persistent cervical infections, effect for reinfection by HPV typing test in one/ two year after vaccination.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

situation of infection with or without HPV 16/18
situation in one/ two year of both group

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Vaccine

Interventions/Control_1

HPV typing test and receive Cervarix

Interventions/Control_2

HPV typing test and not-receive Cervarix

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

40 years-old >

Gender

Female

Key inclusion criteria

1.Sex: female
2.Age: and above 20, under 40
3.patients who have a diagnosis of low-grade squamous intraepithelial lesion (CIN 1) by tissue diagnosis

Key exclusion criteria

1.obvious progression of squamous intraepithelial lesion
2.diagnosis of cervical cancer in past times
3.diagnosis of above middle-grade squamous intraepithelial lesion in past times
4.obvious fever
5.obvious any severe acute disease
6.history of hypersensitivity to any ingredient of Cervarix
7.during pregnancy
8.during lactation
9.receive live vaccine within 27 days
10.receive inactivated vaccine within 6 days

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Tsujioka

Organization

Fukuoka University Hospital

Division name

Department of gynecology

Zip code


Address

7-45-1 nanakuma, jonan-ku, fukuoka, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Fukuoka University Hospital

Division name

Department of gynecology

Zip code


Address

7-45-1 nanakuma, jonan-ku, fukuoka, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Department of gynecology, Fukuoka University Hospital

Institute

Department

Personal name



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

2011 Year 06 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

Open public recruiting

Date of protocol fixation

2011 Year 02 Month 08 Day

Date of IRB


Anticipated trial start date

2011 Year 08 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



Management information

Registered date

2011 Year 05 Month 26 Day

Last modified on

2011 Year 05 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006665


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name