Vaginal intraepithelial neoplasia (VAIN) Cancer Vaginal intraepithelial neoplasia (VAIN)
Conditions
Interventions
Patients enrolled in the study will have an HPV sample taken (with a brush) in addition to the routine samples during an outpatient colposcopy visit. Enrolled patients will be randomized into two grou
Sponsors
Helsinki University Hospital, Women's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Over 18 years of age 2. Histological diagnosis of VAIN 2-3 3. Histological diagnosis of VAIN 1, which has been expectantly managed for two years
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation 2. Lack of reliable contraception in premenopausal patients 3. Known HIV infection 4. Vaginal cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Histological regression (defined as VAIN 1 or less), assessed from punch biopsies 2. HPV clearance, assessed via HPV genotyping from cervical or vaginal brush samples Measured at 2, 4 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete histological regression, assessed from punch biopsies 2. Tolerability of treatment, assessed based on adverse effect reporting on a standardized form from the patients Measured at 2, 4 and 6 months | — |
Countries
Finland
Outcome results
None listed