Aggressive Squamous Cell Carcinoma in Organ Transplant Recipients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02095912

Enrollment

150

Registered

2014-03-26

Start date

2014-03-31

Completion date

2016-01-31

Last updated

2016-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Cell Carcinoma

Keywords

Squamous Cell Carcinoma

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

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

Countries

Switzerland

Outcome results