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

July 25, 2019 updated by: University of Zurich
The investigators hypothesize that a low number of SCC in OTR will metastasize.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Leiden, Netherlands
        • Leiden University Medical Center
  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Division of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

organ transplant recipients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SCC metastasis
organ transplant recipients
Other: SCC metastasis
occurrence of SCC metastasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SCC metastasis detection
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

Leiden University Medical Center

Investigators

  • Principal Investigator: Günther Hofbauer, Prof MD, University Hospital Zurich, Division of Dermatology
  • Study Chair: Jan Nico Bouwes Bavinck, Leiden University Medical Center
  • Study Director: Roel Genders, MD, Leiden University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

October 29, 2013

First Submitted That Met QC Criteria

November 4, 2013

First Posted (Estimate)

November 5, 2013

Study Record Updates

Last Update Posted (Actual)

July 29, 2019

Last Update Submitted That Met QC Criteria

July 25, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCOPE-ITSCC metastases

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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