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.

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. - oKF-RL35

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027014

Enrollment

2000

Registered

2021-12-03

Start date

2020-01-14

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

D06.0 D06.1

Interventions

Group 1: Women over 35 years of age with clinically indicated diagnostic colposcopy with abnormal screening of the cervix uteri in accordance with the guideline for organized cancer screening programs

Eligibility

Sex/Gender

Female

Age

35 Years to 100 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 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 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.	—

Measure

Time frame

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 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 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.

—

Countries

Germany

Contacts

Public ContactZiad Hilal

ZYDOLAB - Institut für klinische Zytologie und Immunzytochemie

z.hilal@zydolab.de0231579349

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026