Aggressive Squamous Cell Carcinoma in Organ Transplant Recipients

Completed

• Conditions: Squamous Cell Carcinoma

• Registration Number: NCT02095912
• Lead Sponsor: University of Zurich

Brief Summary

To identify risk factors for aggressiveness in Squamous Cell Carcinoma of the skin in organ transplant recipients.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-02-18
• Study Start: 2014-03
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-26
• Primary Completion: 2015-11
• Study Completion: 2016-01
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-09
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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Exclusion Criteria

• Non organ transplant recipients

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diameter of Squamous Cell Carcinoma	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

Secondary Outcome Measures

Name	Time	Method
Sun exposure history	1 year	* skin type; * hair colour; * eye colour; * freckles; * cumulative UV exposure; Measurements will be assessed with questionnaire from about 150 participants.

Trial Locations

Locations (1)

Universitätsspital Zürich; 🇨🇭 Zurich, ZH, Switzerland