Prospective study on the use of tissue samples and associated patient data in women with benign and malignant gynaecological conditions

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00040112

Enrollment

1440

Registered

2026-05-04

Start date

2026-10-01

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Patients undergoing cervical cancer screening Z12.4

Interventions

Group 1: The aim of this study is to conduct a comprehensive molecular biological analysis of biological material from patients with benign and malignant gynaecological conditions. As part of routine

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Existing portio uteri

Exclusion criteria

Exclusion criteria: Previous surgical removal of the cervix

Design outcomes

Primary

Measure	Time frame
Development and evaluation of a cervical cancer screening test that identifies inadequate PAP smear samples and, based on specific transcriptional patterns, diagnoses high-grade dysplasia and carcinoma (CIN2+), both HPV-associated and non-HPV-associated, with greater accuracy. Single-step endo- and ectocervical smear collection (inner and outer cervix). In addition, the data is cross-referenced with samples taken previously by external providers (standard PAP smear, HPV test).	—

Measure

Time frame

Development and evaluation of a cervical cancer screening test that identifies inadequate PAP smear samples and, based on specific transcriptional patterns, diagnoses high-grade dysplasia and carcinoma (CIN2+), both HPV-associated and non-HPV-associated, with greater accuracy. Single-step endo- and ectocervical smear collection (inner and outer cervix). In addition, the data is cross-referenced with samples taken previously by external providers (standard PAP smear, HPV test).

—

Secondary

Measure	Time frame
Once the biobank has been established, secondary endpoints will be identified through further studies, if necessary.	—

Countries

Germany

Contacts

Public ContactCarolin Schröder

Universitätsklinik Bonn, Klinik für Gynäkologie und gynäkologische Onkologie

carolin.schroeder@ukbonn.de+4922828715444

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026