Chemoprevention Trial of Acitretin Versus Placebo in Solid Organ Transplant Recipients With Multiple Prior Treated Skin Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 11
- 主要终点
- rate of new primary nonmelanoma skin cancers
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of acitretin may be an effective way to prevent the recurrence or further development of skin cancer.
PURPOSE: Randomized clinical trial to study the effectiveness of acitretin in preventing skin cancers in patients with at least two previously treated skin cancers who have undergone organ transplantation.
详细描述
OBJECTIVES:
- Determine the chemopreventive efficacy of acitretin in immunosuppressed solid organ transplant recipients with a history of multiple previous basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) skin cancer resections.
- Evaluate human papillomavirus (HPV) as a possible etiologic cofactor in the development of cutaneous epidermal dysplasia/carcinoma from skin tissues of these patients.
- Determine the effect of acitretin on potential surrogate endpoint biomarkers and HPV DNA in normal (sun protected), sun-exposed, and dysplastic and carcinoma (SCC/BCC) skin specimens.
OUTLINE: This is a randomized study. Patients are stratified according to age (at least 18 to under 50 vs 50 to 59 vs 60 to 69 vs 70 and over), number of prior skin cancers in past 5 years (2 vs 3 vs at least 4), time since most recent skin cancer occurrence (less than 12 months vs at least 12 months), sunburn susceptibility (none vs moderate vs high), visible skin damage (mild vs moderate vs severe).
Patients receive either oral acitretin or placebo daily for 2 years. Skin biopsies are obtained at 1 year from normal areas and from any areas with skin cancer for genetic studies.
Patients are followed every 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
acitretin
Patients receive oral acitretin daily for 2 years. Skin biopsies are obtained at 1 year from normal areas and from any areas with skin cancer for genetic studies.
Patients are followed every 6 months.
干预措施: acitretin (Drug)
placebo
Patients receive placebo daily for 2 years. Skin biopsies are obtained at 1 year from normal areas and from any areas with skin cancer for genetic studies.
Patients are followed every 6 months.
干预措施: placebo (Other)
结局指标
主要结局
rate of new primary nonmelanoma skin cancers
时间窗: Up to 1.5 years
次要结局
未报告次要终点