To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs. standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Dep. of Gynecology, Krankenhaus Barmherzige Brüder Graz
Graz, Styria, Austria
Dep. of Gynecology and Obstetrics, Landes Frauen- und Kinderklinik Linz
Linz, Upper Austria, Austria
Department of Obstetrics and Gynecology/ Medical University of Graz
Graz, Austria
Complete clinical response
No clinical evidence of vulvar lesion, i.e. 100% reduction of primary lesion size
Time frame: 6 months
Clinical response/ lesion size
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).
Time frame: 6 months
Histologic response
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
Time frame: 6 months
Extent of surgery
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)
Time frame: 6 months
HPV status
HPV status will be measured with the qualitative cobas® HPV Test, Roche, and the the APTIMA ® HPV assay, Gen-Probe.
Time frame: 6 months
Clinical response/lesion size
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Department of Gynecology and Obstetrics, Medical University of Innsbruck
Innsbruck, Austria
Dep. of Gynecology and Obstetrics, Klinikum Klagenfurt
Klagenfurt, Austria
Dep. of Gynecology and Obstetrics
Leoben, Austria
Dep. of Gynecology, Krankenhaus Barmherzige Schwestern Linz
Linz, Austria
Dep. of Gynecology and Obstetrics, Landeskrankenhaus Salzburg
Salzburg, Austria
Department of General Gynecology and Gynecology Oncology, Medical University of Vienna
Vienna, Austria
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).
Time frame: 12 months
Extent of surgery
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)
Time frame: 12 months
HPV status
HPV status will be measured with the qualitative cobas® HPV Test, Roche, and the the APTIMA ® HPV assay, Gen-Probe.
Time frame: 12 months