Cervical cancer
Conditions
Interventions
None listed
Sponsors
The Japanese Society of Clinical Cytology
Department of Diagnostic Pathology, Kumamoto University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1)Women whom close examination is required Women who diagnosed ASC-US or worse within 24 weeks, or suspected cervical abnormalities in past clinical findings Women who can cooperate the specimen collection Women who provided informed consent (2)Women for the pap smear (1st screening test) Women who provided informed
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactMasaru Nakamura
Keio University, School of Medicine Department of Obstetrics and Gynecology
Outcome results
None listed