Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)
The aim of this study is to determine possible molecular changes on large scale gene expression profiling after treatment with Metvix photodynamic therapy (PDT) of actinic keratoses (AK) and cancerised field in renal transplant recipients.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® PDT|
- Skin biopsies to be performed in lesional, peri-lesional skin and in healthy skin to assess gene's expression in each condition. [ Time Frame: Screening and Week 18. ] [ Designated as safety issue: No ]
- Clinical assessment of the AKs present on the target area treated with Metvix PDT. [ Time Frame: Screening, baseline, Week 12, Week 18, Month 9 and Month15. ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
|Experimental: Metvix PDT||
Procedure: Metvix PDT
Methyl aminolevulinate cream will be applied for 3 hours on the whole target field.
The target field will then be exposed to red light using Aktilite 128 lamp.
Other Name: Metvix PDT
Transplant recipients have an increased propensity to develop multiple areas field of cancerisation and subsequently to develop multiple actinic keratoses, which demonstrate an increased transformation rate into invasive squamous cell carcinoma (SCC). The incidence of cutaneous premalignant epithelial lesions such as actinic keratosis (AK) is increased compared with the immunocompetent population with a mean occurrence of 38% after 5 years of immunosuppression, compared with <5% in the immunocompetent patients. Since the development of multiple AKs may portend further possibility extensive cutaneous carcinogenesis, early and aggressive treatment is essential to prevent the progression to invasive SCC.
Although they may occur as single lesion, multiple actinic keratoses (AKs) are commonly present in areas of chronic actinic damage (field of AKs or field of cancerisation). The concept of "field cancerisation" suggests that the clinically normal appearing skin around AKs provides the basis for clonal expansion of genetically altered neoplastic cells. This is called sub-clinical AK lesions.
In this study, the whole target area defined by the investigator will be treated by Metvix PDT: this means that both lesions and sub-clinical lesions will be exposed to Metvix PDT. Biopsies will be performed in both regions: lesional and peri-lesional ones. This will allow us to compare pre and post treatment molecular changes that occurred in these regions and so to evaluate if Metvix PDT acts on the sub-clinical lesions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000636
|Department of Dermatology of Manchester Royal Infirmary|
|Manchester, United Kingdom, M13 9WL|
|Principal Investigator:||John T. Lear, MB,Ch.B,M.D||Manchester Royal Infirmary|