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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000011496

Enrollment

300

Registered

2013-08-19

Start date

2013-08-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Outcome results