C53 D06
Conditions
Interventions
Group 1: 10,000 patients receive a letter of invitation to participate in the study
Group 2: 10,000 patients receive a test kit directly by mail without prior invitation
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
Female
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: Women living in the city or region of Hannover
Exclusion criteria
Exclusion criteria: Pregnancy, hysterectomy in the past
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| I) Comparison of the participation rate of the opt-out and the opt-in study cohort. II) Compliance after a positive HPV test, i.e. how many women with a positive HPV self-sample visit their gynaecologists for a triage cytology smear. III) Comparison between two vaginal self-sampling gadgets and a collection device for first-void urine regarding sample quality. IV) Triaging the HPV positive self-samples using a DNA-methylation test | — |
Secondary
| Measure | Time frame |
|---|---|
| I) Comparison of the self-sampling instruments regarding user-friendliness. II) Evaluation of the rate of HPV positive samples and the percentage of high-risk HPV genotypes III) Evaluation of influencing factors on the participation rate (age, area of living, …) IV) Evaluation of the number of newly diagnosed CIN or invasive cervical cancer. | — |
Countries
Germany
Contacts
Public ContactMatthias Jentschke
FrauenklinikMedizinische Hochschule Hannover
Outcome results
None listed