UMIN-CTR Clinical Trial

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 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
Email	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
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	Hokkaido University School of Medicine
Address	N15, W7, Kitaku, Sapporo
Tel	011-706-5938
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015400