Metastases of Cutaneous Squamous Cell Carcinoma in Organ Transplant Recipients. The “SCOPE-ITSCC Metastases Study”

Overview

The investigators hypothesize that a low number of SCC in OTR will metastasize.

Full Title of Study: “Metastases of Cutaneous Squamous Cell Carcinoma in Organ Transplant Recipients. The “SCOPE-ITSCC Metastases Study””

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2023

Detailed Description

In a large international multicenter prospective observational study a total number of 1000 OTR (organ transplant recipients) with a histologically proven cutaneous SCC (squamous cell carcinoma) will be included in 10 centers and followed during 2 years to establish the cumulative incidence of metastases in OTR with cutaneous SCC.

Interventions

  • Other: SCC metastasis
    • occurrence of SCC metastasis

Arms, Groups and Cohorts

  • SCC metastasis
    • organ transplant recipients

Clinical Trial Outcome Measures

Primary Measures

  • SCC metastasis detection
    • Time Frame: two years

Participating in This Clinical Trial

Inclusion Criteria

  • Organ-transplant recipients (OTR). – Histologically proven cutaneous invasive SCC at time of inclusion Exclusion criteria:

  • Lack of consent. – History of metastases of cutaneous SCC

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Collaborator
    • Leiden University Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Günther Hofbauer, Prof MD, Principal Investigator, University Hospital Zurich, Division of Dermatology
    • Jan Nico Bouwes Bavinck, Study Chair, Leiden University Medical Center
    • Roel Genders, MD, Study Director, Leiden University Medical Center

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