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

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 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

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

Value
https://center6.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