Vulvar Intraepithelial Neoplasia
Conditions
Keywords
VIN, Imiquimod, Surgery, HPV, Patient satisfaction
Brief summary
To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs. standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).
Interventions
DRUGImiquimod
PROCEDURESurgery
Sponsors
Austrian Science Fund (FWF)
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed VIN (only usual type, formerly VIN 2-3) * Visible, measurable lesion(s) * Contraception (for premenopausal women)
Exclusion criteria
* Evidence of invasion * History of cancer or severe inflammatory dermatosis of the vulva * Pregnancy, lactation * Immunodeficiency * Any treatment for VIN within the previous three months * Known hypersensitivity to imiquimod
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete clinical response | 6 months | No clinical evidence of vulvar lesion, i.e. 100% reduction of primary lesion size |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response/ lesion size | 6 months | Vulvar lesions will be described, measured with calipers, mapped and photographed. The digital photos will be analyzed with a computer program (ImageJ) to calculate the total lesion size in cm². Results will be classified as: no response (NR, reduction in lesion size of 25% or less), weak partial response (wPR, 26-75% reduction), strong partial response (stPR, 76%-99% reduction) and Complete response (CR, 100% reduction). |
| Histologic response | 6 months | At baseline punch biopsies will be taken from the affected areas. The site of the initial biopsy will be photodocumented to ensure that the follow-up biopsy at 6 months is taken from the same site. Histologic results will be classified as response (R): complete disappearance of usual type VIN or reduction to VIN1,or no response (NR). All biopsy samples will be analysed independently by two experienced gynecologic pathologists unaware of the treatment allocation |
| Extent of surgery | 6 months | The number, types and extent of surgical procedures will be recorded. The extent of surgery will be recorded as total operated lesion size (in cm², as measured on pre-operative photograph) and relative operated lesion size (percentage of operated lesion size compared with the original pretreatment lesion size) |
| HPV status | 6 months | HPV status will be measured with the qualitative cobas® HPV Test, Roche, and the the APTIMA ® HPV assay, Gen-Probe. |
| Clinical response/lesion size | 12 months | Vulvar lesions will be described, measured with calipers, mapped and photographed. The digital photos will be analyzed with a computer program (ImageJ) to calculate the total lesion size in cm². Results will be classified as: no response (NR, reduction in lesion size of 25% or less), weak partial response (wPR, 26-75% reduction), strong partial response (stPR, 76%-99% reduction) and Complete response (CR, 100% reduction). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immune cells in the epidermis | 6 months | Histochemical analysis of immune cells from vulvar biopsy samples will be performed at baseline and at 6 months. Frozen sections will be prepared and stained with corresponding cell markers. Immune cell populations will be quantified as number of cells per square millimetre and will be compared between the two treatment groups. The following markers and their primary antibodies will be analysed: CD1a, marker for Langerhans cells, CD94, marker for natural killer cells, CD4, marker for T-helper cells, CD8, marker for cytotoxic T-cells and CD207, marker for immature dendritic cells expressing Langerin. |
| Cervical Dysplasia Distress Questionnaire | 6 months | Change from baseline in Cervical Dysplasia Distress score at 6 months |
| Visual analogue scale (VAS) for assessment of pain and pruritus | 6 months | Change of VAS score for pain and pruritus from baseline to 6 months. VAS will be assessed at baseline, 1,2 ,3,4,5 and 6 months. |
| Aesthetic results | 6 months | Detailed photos of the overall vulva will be taken. Photos will be compared to photos taken at baseline and judged by 4 independent, blinded observers for aesthetic results. |
| Cervical Dysplasia Distress questionnaire | 12 months | Change from Baseline in Cervical Dysplasia Distress score at 12 months |
| Fear of Progression Questionnaire | 6 months | Change from Baseline Fear of Progression score at 6 months. |
| Fear of Progression questionnaire | 12 months | Change from Baseline Fear of Progression score at 12 months. |
| Sexual activity Questionnaire | 6 months | Change from baseline Sexual activity score at 6 months |
| Sexual activity questionnaire | 12 months | Change from baseline Sexual activity score at 12 months |
Countries
Austria
Outcome results
None listed