Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma Patients
Malignant MelanomaThe purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine.
Reflectance Confocal Microscopy to Diagnose MM & LM
Melanoma (Skin)Lentigo MalignaA reflectance confocal microscope is a machine which is able to examine the upper layers of the skin painlessly and without the need for taking a biopsy. We would like to examine the images taken by the confocal microscope to see if it can help more accurately identify lesions which are worrying rather than a benign mole. We are performing this study in patients in whom we have recommended excising a mole to exclude a cancer. If the results of the study show that the confocal microscope can help more accurately diagnose Melanomas then this would reduce the number of biopsies that are taken that turn out not to be cancerous (ie unnecessary biopsies).
Appropriate Dosing to Optimise Personalised Cancer Treatments
Melanoma Stage IIIMelanoma Stage IV5 moreThis is a pilot study to assess feasibility of dried blood spot (DBS) samples for pharmacokinetic measurements of targeted anti-cancer drugs in oncology patients such as patients with BRAF-mutant melanoma receiving targeted treatment with BRAF and MEK inhibitors.
Clinical Utility of Electrical Impedance Spectroscopy
Focus of Study: Patients With Suspicion of MelanomaThe purpose of this clinical study is to evaluate the clinical utility of the Nevisense in normal clinical practice, i.e. the potential effect of implementing Nevisense in clinical decision making (Human vs Human & Machine) based on Nevisense measurement at time of biopsy decision.
Defining the Role of the Skin Microbiome in Immune-related Adverse Events
VitiligoSkin MelanomaThe skin microbiome has been implicated in several cutaneous autoimmune pathologies such as psoriasis and atopic dermatitis. However, its role in vitiligo and vitiligo lesions occuring in patients receiving anti-PD-1 for metastatic melanoma
Elevated LDH Serum Levels and FDG-PET in Metastatic Melanoma Patients
MelanomaA retrospective study investigating the relationship between FDG-PET uptake and LDH levels.
Co-stimulatory Markers and Vitamin D Status in Anti-PD1 Treated Melanoma Patients
Malignant MelanomaAn observational single center study designed to identify response-related biomarkers of anti-programmed death 1 (PD-1) therapy to advanced melanoma patients and to investigate if vitamin D levels are related to treatment response. 40 patients diagnosed with advanced melanoma will be included. Patients are included at the Department of Oncology, Aarhus University Hospital (AUH). All patients will be treated with Pembrolizumab as a standard procedure at the Department of Oncology. The protocol comprises blood samples at baseline, 3 and 6 weeks after treatment initiation with anti-PD1 therapy and three years of observational follow-up. A total amount of 217 ml blood will be drawn during the study period. The study period is 6 weeks followed by 3 years of follow-up. Medical history, symptoms, response to treatment regarding the RESIST criteria and side affects will be recorded at each visit in both the study period and in follow-up. Biochemical markers will be obtained according to normal procedure during study and follow-up visits. 20 Healthy volunteers (HV) are included, matched by age and gender. Collected blood samples (serum, plasma, peripheral blood mononuclear cells) will be analyzed after the last patient has ended the week 6 visit.
Quality of Life and Surgical Late Effects of Melanoma Treatment
MelanomaQuality of Life5 moreHealth-related Quality of life in Danish stage IB-III cutaneous melanoma patients.
An Observational Safety Study in Zelboraf (Vemurafenib)-Treated Patients With BRAF-V600 Mutation-Positive...
Malignant MelanomaThis multi-center, prospective, observational safety study will evaluate the safety and effectiveness of Zelboraf (vemurafenib) in a real world setting. Data from Zelboraf-treated patients with BRAF-V600 mutation-positive unresectable or metastatic melanoma will be collected for 2 years.
An Observational Study of BRAF Inhibitors Effectiveness in Patients With Newly Diagnosed Metastatic...
Malignant MelanomaThis observational study will evaluate the effectiveness of BRAF inhibitors and current therapies in patients with newly diagnosed metastatic melanoma with or without BRAF V600 mutation. Patients will be treated per the locally approved therapeutic options in clinical practice. The observation period for each patient will be up to 24 months.