Metastases of cutaneous squamous cell carcinoma in organ transplant recipients - The *SCOPE-ITSCC metastases study*

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 LUMC 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/).

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.

OTR with skin carcinomas are regularly seen in the outpatient dermatological
clinic of the LUMC and other Dutch and foreign specialized out-patient
dermatological OTR clinics. When a patient develops a first or a new SCC, the
patient will be asked to participate in the study. The patient will be asked to
fill in a questionnaire together with the investigator. Patient, tumor,
follow-up data and treatment characteristics will be registered by the
investigator and data about diagnostic procedures will be recorded. Standard
medical care will be given to all patients.

Except for filling in the questionnaire with the help of the investigator,
which will require 5 minutes of time per lesion, there will be no burden for
the patient. There will be no risk in addition to the standard medical care.
All data will be entered in an ACCESS database anonymously. The non-anonymous
printed questionnaire will be kept as a record for the local treating
physician, and will not be used for the data analyses.