Aggressive Squamous Cell Carcinoma in Organ Transplant Recipients

August 9, 2016 updated by: University of Zurich
To identify risk factors for aggressiveness in Squamous Cell Carcinoma of the skin in organ transplant recipients.

Study Overview

Status

Completed

Conditions

Detailed Description

Squamous Cell Carcinomas (SCC) are one of the most common skin cancers. They belong to the epithelial neoplasm of the skin, which manifest a local aggressive growth and have potential for metastasis. Organ transplant recipients have a hundredfold higher incidence of SCC.

Unfortunately the primary tumor, regional nodes, metastasis (TNM)-Classification for the prognosis of SCC in this group of patient has not yet been established. Therefore there are no standardised criteria for evaluation of local recurrence or prognosis.

The aim of this study is to identify criteria, which permit a risk assessment relating to aggressiveness of SCC.

Study Type

Observational

Enrollment (Actual)

150

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

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • Universitätsspital Zürich

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Organ Transplant Recipients with:

  • > 9 Squamous Cell Carcinoma (SCC) in total or
  • > 2 SCC per year (in any one year) or
  • any single "index" SCC that has a very poorly differentiated cell morphology or that behaved aggressively in Terms of local recurrence or local/systemic metastasis

Description

Inclusion Criteria:

Organ transplant recipients with:

  • > 9 SCC in total or
  • > 2 SCC per year (in any one year) or
  • any single "index" SCC that has a very poorly differentiated cell morphology or that behaved aggressively in Terms of local recurrence or local/systemic metastasis

Exclusion Criteria:

  • Non organ transplant recipients

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diameter of Squamous Cell Carcinoma
Time Frame: 1 year
  • Location
  • exact size in mm
  • histological classification (well-differentiated, moderately-differentiated, poorly differentiated, spindle cell morphology, desmoplastic, basi-squamous, acantholytic)
  • Invasion
  • rapid growth
  • local recurrence
  • sentinel node sampling
  • Metastasis
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sun exposure history
Time Frame: 1 year
  • skin type
  • hair colour
  • eye colour
  • freckles
  • cumulative UV exposure

Measurements will be assessed with questionnaire from about 150 participants.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transplantation history
Time Frame: 1 year
Measurements will be assessed with questionnaire from about 150 participants.
1 year

Collaborators and Investigators

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

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Guenther Hofbauer, Prof MD, University Hospital Zurich, Division of Dermatology

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

March 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

March 20, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-2013-0591

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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