Clinical Evaluation of the CINtec® Cytology Dual Stain Kit as a Screening Test as well as a Reflex Test in the Triage of Women with a Pap Cytology Result of ASC-US or LSI
- Conditions
- cervical cancer, High-grade lesion of cervix uteriN87.2Severe cervical dysplasia, not elsewhere classified
- Registration Number
- DRKS00000408
- Lead Sponsor
- mtm laboratories AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 27349
Inclusion Criteria
Women undergoing a routine cervical cancer screening based on Pap cytology testing or women with a Pap cytology result of ASC-US or LSIL based on liquid-based cytology and evaluated according to the Bethesda classification system,
Signed, written informed consent.
Exclusion Criteria
Women who are pregnant,
Women with a history of hysterectomy (except a supracervical hysterectomy),
Women who are unwilling or unable to provide informed consent and/or to adhere to study requirements.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the senitivity and specificity of CINtec cytology Dual Stain for identifying HGCIN (CIN2+/CIN3+) employing the quality-controlled histology diagnosis of cervical biopsies as gold standard.
- Secondary Outcome Measures
Name Time Method Comparison of the sensitivity and specificity of CINtec Cytology Dual Staining for identifying HGCIN with the sensitivity and specificity of the follwing tests: <br>- Pap cytology<br>- HR-HPV test<br>