Skin Cancer in Swiss Transplant Cohort Study

Skin Cancer Clinical Trial

— SCSTCS  

Official title:

Skin Cancer in Swiss Transplant Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02361229
• Other study ID #: KEK-ZH-Nr. 2014-0276
• Status: Active, not recruiting
• Start date: January 2008
• Est. completion date: December 2019

Study information

• Verified date: July 2019
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4000
• Est. completion date: December 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Cancer
• Skin Neoplasms

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Dermatology	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Skin Cancer in SOTRs	skin cancer event	10 years
Primary	Incidence and type of skin neoplasms in STORs	skin neoplasm event	10 years