Aggressive Squamous Cell Carcinoma in Organ Transplant Recipients

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

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Key information

Conditions

Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsspital Zürich

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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.

Other outcomes

Transplantation history

Time frame: 1 year

Measurements will be assessed with questionnaire from about 150 participants.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2016
First posted: Mar 26, 2014
Registry last updated: Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed