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Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)

2014-08-27 03:18:27 | BioPortfolio

Summary

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.

Description

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Actinic Keratosis

Intervention

Metvix PDT

Location

Department of Dermatology of Manchester Royal Infirmary
Manchester
United Kingdom
M13 9WL

Status

Recruiting

Source

Galderma

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:27-0400

Clinical Trials [121 Associated Clinical Trials listed on BioPortfolio]

Metvix Daylight PDT in Actinic Keratosis

Prospective non-interventional study conducted in Australia, Brazil, Mexico and Europe to evaluate clinical practice with Metvix Daylight PDT in the treatment of mild to moderate actinic k...

This Study Aims to Evaluate the Safety and Efficacy of BF-200 ALA for the Treatment of Actinic Keratosis With Photodynamic Therapy (PDT)

The aim of the study is to evaluate the non-inferiority of BF-200 ALA (Ameluz) in the treatment of actinic keratosis with photodynamic therapy (PDT) compared to Metvix.

Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp

The purpose of this study is to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the the LED light source Aktilit...

Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp

The purpose of this study is to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the the LED light source Aktilit...

Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization

Twenty patients with multiple actinic keratosis on the face will be enrolled in the study and will be treated with Daylight Photodynamic therapy. Before and after skin biopsies will be pe...

PubMed Articles [61 Associated PubMed Articles listed on BioPortfolio]

Incidence of Actinic Keratosis and Risk of Skin Cancer in Subjects with Actinic Keratosis: A Population-based Cohort Study.

In vivo Confocal Laser Microscopy for monitoring of actinic keratosis treatment: a comparison with histopathologic assessment after treatment with topical 5% 5-fluorouracil.

Histological examination is the gold standard for actinic keratosis diagnosis; however, it is not always a feasible approach. Reflectance confocal microscopy (RCM) is a non-invasive technique that may...

Swiss (German) Version of the Actinic Keratosis Quality of Life questionnaire.

Actinic keratosis (AK) is a sun-induced skin lesion that may progress to invasive squamous cell carcinoma of the skin. Recently, the Actinic Keratosis Quality of Life questionnaire (AKQoL) was designe...

Actinic keratosis area and severity index (AKASI) is associated with the incidence of squamous cell carcinoma.

Actinic keratoses (AKs) are commonly diagnosed clinically. Actinic keratosis area and severity index (AKASI) is a new easy-to-use tool to assess the severity of AK on the head.

A randomized split-scalp study comparing Calcipotriol assisted MAL-PDT with Conventional MAL-PDT for the treatment of Actinic Keratosis.

Topical photodynamic therapy (PDT) is an approved treatment for actinic keratosis (AK). To enhance the efficacy of PDT for AKs, physical (ablative lasers and microneedling) and chemical (pro-different...

Medical and Biotech [MESH] Definitions

A compound produced from succinyl-CoA and GLYCINE as an intermediate in heme synthesis. It is used as a PHOTOCHEMOTHERAPY for actinic KERATOSIS.

White or pink lesions on the arms, hands, face, or scalp that arise from sun-induced DNA DAMAGE to KERATINOCYTES in exposed areas. They are considered precursor lesions to superficial SQUAMOUS CELL CARCINOMA.

Any horny growth such as a wart or callus.

Benign eccrine poromas that present as multiple oval, brown-to-black plaques, located mostly on the chest and back. The age of onset is usually in the fourth or fifth decade.

A heritable disorder of faulty keratinization characterized by the proliferation of abnormal clones of KERATINOCYTES and lesions showing varying atrophic patches surrounded by an elevated, keratotic border. These keratotic lesions can progress to overt cutaneous neoplasm. Several clinical variants are recognized, including porokeratosis of Mibelli, linear porokeratosis, disseminated superficial actinic porokeratosis, palmoplantar porokeratosis, and punctate porokeratosis.

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