UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003845 |
|---|---|
| Receipt number | 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 09:25:07 |
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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
| Obstetrics 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
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/
tabatat@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Kansai Clinical Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004630
