UMIN-CTR Clinical Trial

Public title

A self-controlled, prospective observational study to evaluate the diagnostic performance of liquid-based cytology (LBC) versus conventional cytology for detecting uterine cervical lesions

Acronym

A self-controlled, prospective observational study to evaluate the diagnostic performance of liquid-based cytology (LBC) versus conventional cytology for detecting uterine cervical lesions

Scientific Title

A self-controlled, prospective observational study to evaluate the diagnostic performance of liquid-based cytology (LBC) versus conventional cytology for detecting uterine cervical lesions

Scientific Title:Acronym

A self-controlled, prospective observational study to evaluate the diagnostic performance of liquid-based cytology (LBC) versus conventional cytology for detecting uterine cervical lesions

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 compare the diagnostic performance between conventional cytology and LBC for detecting the cervical lesions among women with abnormal cytology of ASC-US or worse.

Basic objectives2

Others

Basic objectives -Others

performance comparison

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The difference in diagnostic accuracy between conventional cytology and LBC to detect the cervical lesions of CIN2 or worse with the cutoff level of ASC-US or worse.

Key secondary outcomes

1) The accuracy, sensitivity, specificity, positive predictive value and negative predictive value to detect CIN2 or worse by conventional cytology and LBC with the cutoff level of ASC-US or worse.
2) The accuracy, sensitivity, specificity, positive predictive value and negative predictive value to detect CIN1 or worse by conventional cytology and LBC with the cutoff level of ASC-US or worse.
3) The accuracy, sensitivity, specificity, positive predictive value and negative predictive value to detect CIN3 or worse by conventional cytology and LBC with the cutoff level of ASC-US or worse.
4) The accuracy, sensitivity, specificity, positive predictive value and negative predictive value to detect CIN2 or worse by conventional cytology and LBC with the cutoff value of LSIL or worse.
5) The agreement between conventional cytology and LBC.
6) The frequency of unsatisfactory specimens with conventional cytology and LBC.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

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)Women with abnormal cytology with ASC-US or worse within 24 weeks following informed consent.
3)Participants provided written informed consent.

Key exclusion criteria

1)Women who have had prior cervical invasive cancer.
2)Women who have undergone cervical conization.
3)Women who have undergone hysterectomy.
4)Women who are pregnant.
5)Women are judged ineligible for this trial by physician.

Target sample size

300

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

Name of contact person

1st name
Middle name
Last name

Organization

School of Medicine, Keio University

Division name

Department of Obstetrics and Gynecology

Zip code

Address

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

TEL

Homepage URL

Email

Institute

School of Medicine, Keio University

Institute

Department

Personal name

Organization

Japanese Society of Clinical Cytology

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

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

Date of disclosure of the study information

2013

Year

08

Month

19

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

Completed

Date of protocol fixation

2013

Year

04

Month

22

Day

Date of IRB

Anticipated trial start date

2013

Year

08

Month

19

Day

Last follow-up date

2014

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The aim of this study is to compare the diagnostic performance between conventional cytology and LBC for detecting the cervical lesions among women with abnormal cytology of ASC-US or worse.

Registered date

2013

Year

08

Month

15

Day

Last modified on

2014

Year

08

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013448