UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013203 |
|---|---|
| Receipt number | R000015400 |
| Scientific Title | An investigation of the benefits of HPV co-testing for cervical cancer screening in Hokkaido |
| Date of disclosure of the study information | 2014/03/01 |
| Last modified on | 2021/02/24 12:52:45 |
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Basic information
Public title
An investigation of the benefits of HPV co-testing for cervical cancer screening in Hokkaido
Acronym
An investigation of the benefits of HPV co-testing for cervical cancer screening in Hokkaido
Scientific Title
An investigation of the benefits of HPV co-testing for cervical cancer screening in Hokkaido
Scientific Title:Acronym
An investigation of the benefits of HPV co-testing for cervical cancer screening in Hokkaido
Region
| Japan |
Condition
Condition
cervical cancer and cervical intraepithelial neoplasia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of combined conventional cytology and HPV testing that detects high-risk HPVs and HPV type 16/18 for cervical cancer screening
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correspondence of high-risk HPV positivity and HPV16/18 positivity to age, cytological diagnosis (NILM, ASC-US, >=LSIL) and histological diagnosis (>=CIN2, >=CIN3)
Key secondary outcomes
1. Detection rate of cervical lesion (>=CIN2, >=CIN3) by combined cytology and HPV testing as compared to the rate by cytology only which was done in the same period of the research or previously.
2. Incidence of >=CIN2 or >=CIN3 after 3 years in connection with the HPV testing results
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
| Device,equipment |
Interventions/Control_1
Combined conventional cytology and HPV testing will be performed between March 2014 and December 2018 at the Hokkaido University Hospital. Women with both negative cytology result and HVP (-)/non-HPV type 16/18(+) will return to routine screening. Women with negative cytology associated with positive HPV16/18 will undergo colposcopy. Women with ASC-US associated with HPV(+) will undergo coloposcopy. Women with LSIL or more will undergo colposcopy.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1. Women who cooperate with cervical cytology and HPV test sampling.
2. Women who cooperate with colposcopy and punch biopy if necessary.
3. Women who give written informed consent to entering the study after receiving appropriate explanation, with sufficient understanding by her own discretion.
Key exclusion criteria
1. Women who did not consent.
2. Women less than 20 years old
3. Women over 70 years old
4. Women in pregnancy
5. Women who was judged as inappropriate for the study by a doctor
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | Noriaki |
| Middle name | |
| Last name | Sakuragi |
Organization
Hokkaido University
Division name
Departments of Obstetrics and Gynecology
Zip code
060-8638
Address
Kita15, Nishi7 Kita-ku, Sapporo 060- 8638 Japan
TEL
011-706-5939
sakuragi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | Sakuragi |
Organization
Hokkaido University
Division name
Departments of Obstetrics and Gynecology
Zip code
060-8638
Address
Kita15, Nishi7 Kita-ku, Sapporo 060- 8638 Japan
TEL
011-706-5938
Homepage URL
sakuragi@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Gynecology, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Roche Diagnostic Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hokkaido Cancer Society
Sapporo Medical University
Asahikawa Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University School of Medicine
Address
N15, W7, Kitaku, Sapporo
Tel
011-706-5938
nsakuragi@jcom.home.ne.jp
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
| 2014 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5989866/pdf/CAS-109-2003.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5989866/pdf/CAS-109-2003.pdf
Number of participants that the trial has enrolled
14644
Results
We conducted a 3-year prospective study with14,644 women undergoing routine screening. Conventional cytology and HPV testing were carried out. Women with abnormal cytology or HPV 16/18 positive underwent colposcopy. Those with 12 other high-risk(hr) HPV types underwent repeat cytology after 6 months. HPV 16/18 were detected in 8/8 (100%) invasive cervical cancers, 2/2 (100%) adenocarcinomas in situ. This study suggested the role of partial genotyping and cytology in an HPV based screening program.
Results date posted
| 2021 | Year | 02 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants of the routine cervical screening
Participant flow
Conventional cytology and HPV testing were carried out.
Adverse events
none
Outcome measures
CIN2 or greater cervical lesions
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 19 | Day |
Last modified on
| 2021 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015400
