Evaluation of p16 IHC as a diagnostic tool in diagnosing melanoma.
Research type
Research Study
Full title
The evaluation of p16 immunohistochemistry as an ancillary diagnostic tool in the diagnosis of melanoma.\n
IRAS ID
241241
Contact name
Rosadel Salita
Contact email
Sponsor organisation
Kingston Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 6 months, 13 days
Research summary
The diagnosis and differentiation between benign and malignant melanocytic tumors is subject to considerable subjectivity and inter-observer variability. To date the gold standard for the accurate diagnosis of these suspicious pigmented lesions is histopathological examination with Haematoxylin and Eosin (H&E) staining, this allows consultants to observe the cells and determine if the lesion in question is of a benign or malignant nature. Where cases prove difficult other tests are performed, such as immunohistochemistry tests which aids this diagnosis, biomarkers such as Ki67 (nuclear proliferation marker) and HMB45 (detects immature/activated melanocytes) are typically performed. At present HMB45 immunohistochemistry is one of the most reliable biomarkers for evaluating the severity of dysplasia/irregular cell growth in skin lesions, however it is limited. To date no single biomarker is accurate enough to distinguish melanomas from nevi. Where these biomarkers fail to achieve an accurate diagnosis, molecular methods such as Fluorescent in situ Hybridization (FISH) and DNA microarray’s can be employed, however, these methods require expensive equipment and are not feasible in most NHS laboratories. p16 is a protein involved in regulating the cell cycle and preventing uncontrolled cell growth which could lead to cancer. Some research implies p16 is conserved in benign nevi and frequently lost in melanomas, although p16 IHC is not routinely employed in the investigation of melanomas within the laboratory setting. This project will involve the testing a range suspicious skin lesions, representing differing diagnosis of benign, primary and metastatic melanomas in order to determine if p16 could be a valuable ancillary diagnostic tool in the diagnosis of melanomas and how its test performance compares to that of the routinely used biomarker HMB45.\nPlease note this is not a new technology or new test, it is simply using routine procedures, tests and antibodies available in the lab.
REC name
London - Hampstead Research Ethics Committee
REC reference
18/LO/0373
Date of REC Opinion
22 Feb 2018
REC opinion
Favourable Opinion