SCOPE-ITSCC Metastases Study
Research type
Research Study
Full title
Metastases of cutaneous squamous cell carcinoma in organ transplant recipients
IRAS ID
153455
Contact name
Lorna J Mackintosh
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Research summary
Background and rationale
Skin cancer is the most common cancer in white populations. Organ transplant recipients (OTR) have a highly increased risk of cutaneous squamous cell carcinoma (SCC) and many OTR develop multiple SCC. SCC have the potential to metastasize, usually within 1 year after the initial diagnosis. The risk of metastases varies in the immunocompetent population between 0.1% and 9.9%. Immunosuppression is often mentioned as a risk factor for developing metastases, but in our clinical practice we do not often see OTR with SCC metastases. No prospective clinical studies are available to estimate the cumulative incidence of SCC metastases in OTR.In a large international multicenter prospective observational study a total number of 1000 OTR with a histologically proven cutaneous SCC will be included in 10 centers and followed during 2 years to establish the cumulative incidence of metastases in OTR with cutaneous SCC. This study will be coordinated by the department of dermatology of the Leiden University Medical Centre and will be performed in collaboration with SCOPE (Skin Care in Organ transplant recipients in Europe, http://www.scopenetwork.org/) and ITSCC (International Transplant Skin Cancer Collaborative, http://www.itscc.org/).
Objective
The objective of this multicenter prospective observational study is to estimate in a follow-up period of 2 years the cumulative incidence of metastases in OTR with cutaneous invasive SCC. In addition we will estimate the contribution of risk factors for metastases in these patients such as tumor localization, size, depth and grade, perineural tumor invasion and other potential risk factors to facilitate the design of a future case control study to asses the importance of these risk factors for the development of SCC metastases in OTR.REC name
East of Scotland Research Ethics Service REC 1
REC reference
14/ES/1047
Date of REC Opinion
31 Jul 2014
REC opinion
Favourable Opinion