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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013203
Receipt No. 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 2018/08/28

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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
Obsterics 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
Middle name
Last name Noriaki Sakuragi
Organization Hokkaido University
Division name Departments of Obstetrics and Gynecology
Zip code
Address Kita15, Nishi7 Kita-ku, Sapporo 060- 8638 Japan
TEL 011-706-5939
Email sakuragi@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriaki Sakuragi
Organization Hokkaido University
Division name Departments of Obstetrics and Gynecology
Zip code
Address Kita15, Nishi7 Kita-ku, Sapporo 060- 8638 Japan
TEL 011-706-5938
Homepage URL
Email sakuragi@med.hokudai.ac.jp

Sponsor
Institute Department of Gynecology, Hokkaido University Graduate School of Medicine
Institute
Department

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
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
2014 Year 03 Month 01 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 No longer recruiting
Date of protocol fixation
2014 Year 02 Month 28 Day
Date of IRB
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
2018 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015400

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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