UMIN-CTR Clinical Trial

Public title

Randomized controlled trial to evaluate the efficacy of concurrent liquid-based cytology (LBC) and HPV DNA testing versus LBC alone for the primary cervical cancer screening

Acronym

Cervical cancer screening trial by randomization of HPV testing intervention for upcoming screening (CITRUS study)

Scientific Title

Randomized controlled trial to evaluate the efficacy of concurrent liquid-based cytology (LBC) and HPV DNA testing versus LBC alone for the primary cervical cancer screening

Scientific Title:Acronym

Cervical cancer screening trial by randomization of HPV testing intervention for upcoming screening (CITRUS study)

Region

Japan

Condition

cervical cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of this study is to assess efficacy of the screening with concurrent liquid-based cytology and HPV DNA testing for the primary cervical cancer screening over 7 years.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The incidence of CIN3 or worse during whole periods

Key secondary outcomes

1) The incidence of CIN3 or worse at baseline, and two years, four years, and six years post baseline
2) The incidence of CIN2 or worse at baseline, and two years, four years, and six years post baseline
3) The incidence of CIN1 or worse at baseline, and two years, four years, and six years post baseline
4) The incidence of invasive cancer at baseline, and two years, four years, and six years post baseline
5) The number of cervical cytology performance
6) The number of colposcopy and biopsy performance

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Cervical cancer screening by using liquid based cytology as a standard screening modality

Interventions/Control_2

Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentary screening modality

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

30

years-old

<=

Age-upper limit

65

years-old

>

Gender

Female

Key inclusion criteria

1) Women aged 30-64 years old.
2) Participants provided written informed consent.

Key exclusion criteria

1) Women who will receive planed HPV DNA testing by local governmental cervical cancer program next six years.
2) Women who have had cervical invasive cancer before.
3) Women who have underwent cervical conization.
4) Women who have underwent hysterectomy.
5) Women who have had or have the cytological abnormalities and are under follow-up.
6) Pregnant women.
7) Women judged ineligible for this trial by physician.

Target sample size

30000

Name of lead principal investigator

1st name
Middle name
Last name	Daisuke Aoki

Organization

School of Medicine, Keio University

Division name

Department of Obstetrics and Gynecology

Zip code

Address

35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan

TEL

03-3353-1211(62391)

Email

aoki@z7.keio.jp

Name of contact person

1st name
Middle name
Last name	Daisuke Aoki

Organization

School of Medicine, Keio University

Division name

Department of Obstetrics and Gynecology

Zip code

Address

35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan

TEL

03-3353-1211(62391)

Homepage URL

Email

aoki@z7.keio.jp

Institute

The Japanese Society of Clinical Cytology

Institute

Department

Personal name

Organization

The Japanese Society of Clinical Cytology

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

本研究に協力している41カ所（山梨県）および19カ所（千葉県柏市）の検診実施施設

Date of disclosure of the study information

2013

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2013

Year

04

Month

22

Day

Date of IRB

Anticipated trial start date

2013

Year

06

Month

01

Day

Last follow-up date

2021

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

05

Month

30

Day

Last modified on

2015

Year

12

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012696