Skin Cancer in Swiss Transplant Cohort Study (SCSTCS)

It's known that organ transplant recipients with long-term drug-induced immunosuppression have a increase of the life-time incidence of squamous cell carcinoma. This study will analyze the incidence and type of skin cancer in the Swiss Transplant Cohort Study and the association with exposure to immunosuppressive and antiinfective drugs and other parameters like age or gender of organ transplant recipients.

Study Overview

• Status: Unknown
• Conditions: Skin Cancer

Detailed Description

Organ transplant recipients with long-term drug-induced immunosuppression have an increase of the life-time incidence of squamous cell carcinoma and are also affected at an earlier age than the general population. In organ transplant recipients prognosis of squamous cell carcinoma differs due to more rapid growth, less differentiation and higher risk for metastases in comparison to the general population. Epidemiological data indicate that the risk of skin neoplasms in organ transplant recipients is related to the cumulative exposure to immunosuppressive drugs over time. It remains unclear wether this risk differs between drug classes.

This study is a prospective observational cohort study of kidney, heart, lung, liver, pancreas and small bowel transplant recipients enrolled into the Swiss Transplant Cohort Study (STCS).

Since 2008 almost all organ transplant recipients in Switzerland are enrolled to the STCS. The STCS collects

• baseline patient and case data: date of transplantation, age, gender, type of transplanted organ, past immunosuppression
• follow-up patient and case data: organ rejection with type and date of rejection, type of immunosuppression in response to organ rejection, graft loss with date of graft loss, immunosuppressive drug treatment, other drug treatment, death, drop out, occurrence of cancer and infections)
• drug exposure data (with start and stop dates): induction immunosuppressive drugs (Basiliximab, Rituximab, Thymoglobulin, ATG, ATGAM, IG iv, Plasmapheresis), maintenance immunosuppressive drugs (Cyclosporine A, Glucocorticoids, Tacrolimus, Mycophenolate mofetil, Everolimus, Azathioprine, Sirolimus, EC-MPA), infectious disease prophylaxis (e.g. TM-Sulfamethoxazole, Valaciclovir, Fluconazole, Atovaquone, Voriconazole, Quinolone), other drugs (e.g. Statins, beta-Blockers, oral antidiabetics).

The investigators will statistically illustrate the incidence, prevalence and type of skin neoplasms in the STCS. The investigators will show the association of the incidence of skin neoplasms and the exposure to different immunosuppressive drugs, other drugs and other parameters in the STCS (e.g. age, gender).

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8091
    • University Hospital Zürich, Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Solid organ transplant recipients within the STCS.

Description

Inclusion Criteria:

• solid organ transplant recipients within the STCS
• patients with multiple organ transplantations will be included as well
• patients within the STCS, who gave the informed consent to use their data
• patients with graft loss will remain in the study, since they remain at risk of skin cancer development

Exclusion Criteria:

• organ transplant recipients of non-solid organs (e.g. hematopoetic stem cell transplantation) within the STCS

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Skin Cancer in SOTRs	skin cancer event	10 years
Incidence and type of skin neoplasms in STORs	skin neoplasm event	10 years

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Günther Hofbauer, Prof MD, University Hospital Zürich, Dermatology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Actual): December 1, 2017
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 5, 2015
• First Submitted That Met QC Criteria: February 10, 2015
• First Posted (Estimate): February 11, 2015

Study Record Updates

• Last Update Posted (Actual): July 29, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: KEK-ZH-Nr. 2014-0276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Share data with Swiss Transplant Cohort Study. Future projects can obtain data after project request is approved.
• IPD Sharing Time Frame: 2019-2080
• IPD Sharing Access Criteria: STCS scientific committee approval and ethical committee approval (IRB)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR