''Assessing the link between penile lichen sclerosus and penile cancer
Research type
Research Study
Full title
''Assessing the link between penile lichen sclerosus and penile cancer
IRAS ID
269113
Contact name
Christopher Bunker
Contact email
Sponsor organisation
University College London (UCL)
Clinicaltrials.gov Identifier
Z6364106/2019/11/35, UCL data protection
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The study is concerned with the progression of male genital skin disease lichen sclerosus (MGLSc) to penile (squamous cell) cancer (PSCC).
MGLSc is an uncommon skin disease of the uncircumcised male. Common consequences of MGLSc include inflammation and scarring resulting in sexual and urological difficulties, and an increased risk of developing PSCC.
PSCC is a relatively rare malignancy in the UK. Worldwide it is mainly seen in undeveloped countries where circumcision is not routinely practiced. The pathway to PSCC is twofold via precancerous situations (penile intraepithelial neoplasia -PeIN) either due to MGLSc or infection with the human papilloma virus (HPV).
The aim of this study is to investigate the pathway of genetic mutations that lead to PSCC from MGLSC and PeIN. To do so, we seek to test diseased penile tissue that is obtained from circumcisions or biopsies. We only seek to analyse samples taken as part of routine medical care and will not obtain any additional samples. We are also asking to use tissue that is in storage and has been consented for use in research.
We will identify eligible patients through our outpatient dermatological and urological clinics. We will also identify eligible stored samples with one of the three conditions in question.
Medical procedures will take place at University College London Hospitals (UCLH). Genetic and HPV testing will be performed at University College London (UCL), King’s College London (KCL), and at DDL laboratories in Rijswijk, Netherlands.
Samples will undergo different types of genetic testing in order to identify the range of mutations seen within each condition. We will then attempt to find correlations in the mutations seen in MGLSc, PeIN, and PSCC. We will also test the samples for the presence of the HPV virus in order to understand its role in the carcinogenic pathway.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0037
Date of REC Opinion
30 Jan 2020
REC opinion
Favourable Opinion