The clinical study to evaluate the utility of LC-1000 (exfoliative cell analyzer) for cervical cancer testing

Not Applicable

• Conditions: Cervical cancer

• Registration Number: JPRN-UMIN000019502
• Lead Sponsor: The Japanese Society of Clinical Cytology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-18
• Study Completion: 2017-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 930

Inclusion Criteria

Not provided

Exclusion Criteria

Women who have had cervical invasive cancer before. Women who have underwent cervical conization or hysterectomy before. Pregnant women Women judged ineligible for this study by investigator.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference of the Accuracy (Sensitivity for the "Disease case" defined as CIN2 or worse) and Specificity for the "Non-Disease case" defined as the case that dysplasia is not confirmed in this study period ) between the new test by LC-1000 analyzer and HPV test.

Secondary Outcome Measures

Name	Time	Method
Accuracy (Sensitivity and Specificity) between LC-1000 test and cytology for the detection of CIN2 or worse. Accuracy (Sensitivity and Specificity) between LC-1000 test and other test (combination or alone test by cytology, HPV test) for the detection of CIN3 or worse.