Skin Cancer in Swiss Transplant Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Incidence of Skin Cancer in SOTRs
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Hour 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •organ transplant recipients of non-solid organs (e.g. hematopoetic stem cell transplantation) within the STCS
结局指标
主要结局
Incidence of Skin Cancer in SOTRs
时间窗: 10 years
skin cancer event
Incidence and type of skin neoplasms in STORs
时间窗: 10 years
skin neoplasm event
次要结局
未报告次要终点