Squamous cell carcinoma prevention in organ transplant recipients using topical treatments: a feasibility study (SPOT)

Queen Mary University of London (UK)0 个研究点目标入组 101 人开始时间: 2014年7月10日最近更新: 2020年6月8日

适应症

试验速览

暂无简介。

•1. Organ Transplant Recipient (OTR) Patient Group:
•1.1. OTRs aged >18 years
•1.2. A minimum of 10 AK (with at least 5 AK occurring within the same skin zone)
•1.3. Demonstrably stable renal function on the basis of serum creatinine and estimated Glomerular Filtration Rate (eGFR)
•1.4. No recent change in immunosuppressive medication and predicted to remain stable over course of the study
•1.5. Able to apply topical cream as directed to the required area or having a carer who agrees to do this at the required
•frequency and times
•1.6. Women of childbearing potential, or men in a relationship with a woman of childbearing potential, prepared to adopt
•adequate contraceptive measures if sexually active
•1.7. Able to give written informed consent
•1.8. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
•2. Immunocompetent Patient Group (participating in the DCE substudy only):
•2.1. ICP patients aged >18 years
•2.1. Present or previous AK (any site, any number)
•2.3. Able to give written informed consent
•2.4. Willing to spend up at least 20 minutes completing the Long Q

•Organ Transplant Recipients (OTR) only:
•1. Pregnant (female patients of child bearing potential should have a urine or blood Human Chorionic Gonadotropin
•(hCG) test performed to rule out pregnancy prior to trial entry)
•2. Lactating females. Patients who agree to discontinue nursing 14 days prior to commencing treatment and do not
•nurse throughout all the treatment period are eligible
•3. Life expectancy less than 12 months
•4. Known hypersensitivity or intolerance to 5-fluorouracil, imiquimod, sunscreen, or to any of the excipients (including but
•not limited to: methylhydroxybenzoate, propylhydroxybenzoate, cetyl alcohol, stearyl alcohol, polysorbate 60, propylene
•glycol, methyl parahydroxybenzoate and white soft paraffin)
•5. The use of brivudine, sorivudine and analogues is prohibited

发起方

Queen Mary University of London (UK)