dVIN caused by Lichen Sclerosus
Conditions
Brief summary
To assess effectiveness of MTX in prevention of recurrence in dVIN, recurrence rates with or without MTX will be compared within this prospective self-controlled pilot study, as each patient functions as its own control., Time-to recurrence of dVIN in women with lichen sclerosus and recurrent dVIN lesions with- and without the use of MTX will also be assessed by determination of clinical responses at 1-3-6-9-12-15-18 months and will be identified as stable disease (SD) or progressive disease (PD).
Detailed description
Safety and tolerability of side effects, reduction of vulvar complaints, reduction of topical corticosteroid application and patient satisfaction with the use of MTX will be evaluated by patient reported use and documentation of side effects using a questionnaire. Severity of side effects will be evaluated according to the CTCEA version 5.0 2017., Pre-treatment and, when performed, current- or post-treatment biopsies will be identified and central blinded pathology revision will be performed. To explore microenvironment in recurrent dVIN with and without the use of MTX immunohistochemistry staining, including p53 will be performed.
Interventions
Sponsors
Amsterdam UMC Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess effectiveness of MTX in prevention of recurrence in dVIN, recurrence rates with or without MTX will be compared within this prospective self-controlled pilot study, as each patient functions as its own control., Time-to recurrence of dVIN in women with lichen sclerosus and recurrent dVIN lesions with- and without the use of MTX will also be assessed by determination of clinical responses at 1-3-6-9-12-15-18 months and will be identified as stable disease (SD) or progressive disease (PD). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of side effects, reduction of vulvar complaints, reduction of topical corticosteroid application and patient satisfaction with the use of MTX will be evaluated by patient reported use and documentation of side effects using a questionnaire. Severity of side effects will be evaluated according to the CTCEA version 5.0 2017., Pre-treatment and, when performed, current- or post-treatment biopsies will be identified and central blinded pathology revision will be performed. To explore microenvironment in recurrent dVIN with and without the use of MTX immunohistochemistry staining, including p53 will be performed. | — |
Outcome results
None listed