cervical (pre)malignant disease high risk human papillomavirus (voorstadia van) baarmoederhalskanker hoogrisico humaan papillomavirus
Conditions
Interventions
None listed
Sponsors
VU University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women 18-70 years of age; 2. Cervical smear is hr-HPV DNA positive; 3. Intact cervix (no history of LEEP or surgical treatment involving damage to transformation zone of the cervix); 4. To be able to undergo colposcopy (according to gynaecologist); 5. Sufficient knowledge of the Dutch or English language; 6. To be able to understand the content of the research study; 7. Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Women unable to take a self-sample (including a physical or mental handicap); 2. Cervical smear is hr-HPV DNA negative; 3. Cervical cancer within the preceding 2 years; 4. Presence of any cancer but cervical cancer; 5. History of surgery on cervix; 6. Withdrawal of the informed consent by the patient; 7. Pregnancy or having been pregnant in the last 3 months; 8. Breast-feeding, or breast-feeding in the last 3 months; 9. Heavy bleeding (menstruation or other cause) or excessive vaginal discharge that makes it not possible for colposcopy to be performed. Enrolment into the study will be postponed till condition is resolved and judged by gynaecologists.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endpoint is histology outcome; i.e. presence or absence of ≥CIN2 lesions. | — |
Contacts
Public ContactC.J.L.M. Meijer
VU University Medical Center, Department of Pathology, De Boelelaan 1117
Outcome results
None listed