Aggressive Squamous Cell Carcinoma in Organ Transplant Recipients

Squamous Cell Carcinoma Clinical Trial

Official title:

Aggressive Squamous Cell Carcinoma in Organ Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095912
• Other study ID #: KEK-ZH-2013-0591
• Status: Completed
• Phase: N/A
• First received: February 18, 2014
• Last updated: August 9, 2016
• Start date: March 2014
• Est. completion date: January 2016

Study information

• Verified date: August 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma

Locations

Country	Name	City	State
Switzerland	Universitätsspital Zürich	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Transplantation history	Measurements will be assessed with questionnaire from about 150 participants.	1 year	No
Primary	Diameter of Squamous Cell Carcinoma	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	No
Secondary	Sun exposure history	skin type; hair colour; eye colour; freckles; cumulative UV exposure; Measurements will be assessed with questionnaire from about 150 participants.	1 year	No