Development and Validation of Prognostic Molecular Biomarker for cSCC
Research type
Research Study
Full title
Development and Validation of Prognostic Molecular Biomarkers in the Peri-tumoural Tissue of Cutaneous Squamous Cell Carcinoma
IRAS ID
325810
Contact name
Nikoletta Opauszki
Contact email
Sponsor organisation
York St John University
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
The incidence rate of epidermal keratinocyte- derived cutaneous squamous cell carcinoma (cSCC) is increasing worldwide and is regarded as the second most common skin cancer capable of spreading to other part of the body. It comprises 20% of all keratinocytic skin tumours, accounting for >44,672 annual cases in the United Kingdom. The reported 3 -year disease-specific survival rate for a newly diagnosed patient is 85%, and this is reduced to <2 years if spread to other areas of the body has occurred. The estimated recurrence rate is between 10-30% when pathological margins are reported 'clear' of tumour cells.
The aim of the study is to develop and validate prognostic biomarkers of post-surgical disease recurrence in cutaneous squamous cell carcinoma (cSCC). There are a number of tumour markers that this study will target based on previous molecular margin analysis. Without novel molecular tumour markers, defining the true marginal status of cSCC is merely based on prediction with no scientific credibility. Validation of prognostic tumour markers hold the potential not only to drastically change the current clinical practice but to also to standardise management of post-surgical tumour environment.
The study will be based on the initial identification of any potential immunohistochemical tumour marker in a small retrospective cohort of at least 50 to 100 formalin-fixed paraffin embedded (FFPE) cSCC patient samples. Samples will be identified and retrieved from York Teaching Hospital, pathology department database. These retrospective samples will have been previously identified for cSCC diagnosis. Archived samples will be selected according to the following histological and disease criteria: anatomical site, size, tumour depth, perineurial invasion, histological differentiation, histological type, tumour recurrence and the immunocompetence status of the participant. This will help to draw conclusion of the clinical significance of tumour marker detection in the surgical margin of cSCC tumour.
REC name
Wales REC 7
REC reference
24/WA/0088
Date of REC Opinion
14 Mar 2024
REC opinion
Favourable Opinion