Detection of cervical precancerous lesions by co-testing in women aged 35 and over.First experiences in connection with the new, organized cervical cancer early detection program in Germany.

• Conditions: D06.0; D06.1; Endocervix; Exocervix

• Registration Number: DRKS00027014
• Lead Sponsor: ZYDOLAB - Institut für klinische Zytologie und Immunzytochemie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-03
• Study Completion: 2022-12-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 1956

Inclusion Criteria

Clinically indicated colposcopy for abnormal screening of the cervix uteri in accordance with the guideline for organized cancer screening programs (oKFE-RL)
- Complete clarification colposcopy with present histological result after colposcopy
- Age =35 years

Exclusion Criteria

- incomplete documentation
- pregnancy
- Patients younger than 35 years
- Post-Conization within the last 36 months
- Confirmed precancerosis of the cervix uteri within the last 36 months

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pretest probability for the presence of a CIN2 + lesion on the cervix uteri based on the cytological (PAP test) and virological (HPV test) initial findings.

Secondary Outcome Measures

Name	Time	Method
1) Pretest probability for the presence of a CIN 3+ lesion on the cervix uteri based on the cytological (PAP test) and virological (HPV test) initial findings<br>2) Post-test probability for the presence of a CIN 2+ lesion on the cervix uteri based on the cytological (PAP test) and virological (HPV test) findings in combination with the colposcopic findings<br>3) Post test probability for the presence of a CIN 3+ lesion on the cervix based on the cytological (PAP test) and virological (HPV test) initial findings in combination with the colposcopic findings.