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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003845
Receipt No. R000004630
Scientific Title Prevention of HPV re-infection by HPV vaccination after conization in patients with CIN 3
Date of disclosure of the study information 2010/07/01
Last modified on 2015/12/31

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Basic information
Public title Prevention of HPV re-infection by HPV vaccination after conization in patients with CIN 3
Acronym Prevention of HPV re-infection by HPV vaccination (PHP trial)
Scientific Title Prevention of HPV re-infection by HPV vaccination after conization in patients with CIN 3
Scientific Title:Acronym Prevention of HPV re-infection by HPV vaccination (PHP trial)
Region
Japan

Condition
Condition Cervical intraepithelial neoplasia 3
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the prophylactic effect of post-conization HPV vaccination on HPV 16/18 re-infection in comparison with prior rates of post-conization HPV infection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Investigation on Post-conization HPV infection rate.
2. Investigation on post-conization HPV re-infection prophylazis.
Key secondary outcomes 1. Rate of recurrence of CIN
2. Significant adverse reactions to HPV vaccination

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 HPV vaccination after coniztion
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
40 years-old >
Gender Female
Key inclusion criteria Cohort for post-conization HPV infection
1)Age below 40 years at the time of conization.
2)Performance status (PS) 0 to 1.
3)Diagnosis of CIN 3 confirmed with conization at least 1 year and less than 3 years before.
4)Written voluntary consent to participate in the study after receiving a full explanation of the study details using a given informed consent document and other written information.



Cohort for post-conization HPV vaccination
1)Age below 40 years.
2)PS 0 to 1.
3)Patients who are scheduled for conization for CIN 3 diagnosed with histology and colposcopy and who consent to receive an HPV vaccine (Cervarix) after conization (informed consent should be obtained prior to conization).
4)Patients who have been suspected to have CIN 3 before conization but are found to have minor invasive cancer after conization and receive HPV vaccination with the uterus preserved; these patients are considered eligible for the study.
5)Patients who have been included in the cohort for post-conization HPV vaccination but are found to be pregnant after vaccination and cannot complete 3 HPV vaccinations; these patients are also considered eligible and will be analyzed.
6)Patients who are found to be pregnant after being included in the cohort for post-conization HPV vaccination and completing 3 HPV vaccinations; these patients are also considered eligible for the study.
7)Written voluntary consent to participate in the study after receiving a full explanation of the study details using a given informed consent document and other written information.
Key exclusion criteria 1)Adenocarcinomas
2)Previous HPV vaccination
3)Age of 40 years or over
4)Invasive cancer suggested with cytology, histology, and/or colposcopy before conization.
5)Patients who are found to have invasive cancer or who undergo hysterectomy from their own will after conization should be excluded from the study even after enrollment.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Tabata
Organization Mie University School of Medicine
Division name Obstetrics and Gynecology
Zip code
Address Edobashi 2-174, Tsu city, Mie, Japan
TEL 059-232-1111
Email tabatat@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsutomu Tabata
Organization Mie University School of Medicine
Division name Obstetrics and Gynecology
Zip code
Address Edobashi 2-174, Tsu city, Mie, Japan
TEL 059-232-1111
Homepage URL http://www.kcog.jp/
Email tabatat@clin.medic.mie-u.ac.jp

Sponsor
Institute Kansai Clinical Oncology Group
Institute
Department

Funding Source
Organization Kansai Clinical Oncology Group
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Sankai Gynecologic Study Group
Other Gynecologic Study Group
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 KCOG G-1002
Org. issuing International ID_1 Kansai Clinical Oncology Group
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 三重大学(三重県)
関西労災病院(兵庫県)
岐阜大学(岐阜県)
大阪府立成人病センター(大阪府)
神戸アドベンチスト病院(兵庫県)
静岡がんセンター(静岡県)
聖マリアンナ医科大学(神奈川県)
富山大学(富山県)
名古屋市立大学(愛知県)
奈良県立奈良病院(奈良県)
兵庫医科大学(兵庫県)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 01 Day

Related information
URL releasing protocol http://www.kcog.jp/
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
2010 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2017 Year 12 Month 01 Day
Date of closure to data entry
2017 Year 12 Month 01 Day
Date trial data considered complete
2017 Year 12 Month 01 Day
Date analysis concluded
2018 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 29 Day
Last modified on
2015 Year 12 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004630

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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