Active clinical trials for "Melanoma"

The goal of this study is to find out if some people are more likely to get melanoma, a form of skin cancer, than others. People respond to the environment in different ways. Some may be born with genes that make them more likely to get this type of skin cancer. Genes are made up of DNA. DNA damage is one of the first steps in developing cancer. Each person has many ways to repair normal damage to their genes. Some people may have a lower level of this repair and that may make them more likely to get cancer. Some genes are important for DNA repair. The genes we want to test are thought to affect the rate at which DNA can be repaired. We also want to find out if sun habits are related to these levels of DNA repair or genetic mutations.

Primary Objectives: To establish a statistically significant database: With Spectroscopic Oblique-Incidence Reflectometry (OIR) experimental system, we will obtain OIR spatio-spectral images of 1,000 human skin non-melanocytic and melanocytic lesions that, based on clinical diagnosis, are routinely biopsied and submitted for histopathologic diagnosis and of the adjacent normal skin for self-referencing. The experimental database will contain demographic information, clinical diagnoses, clinical images, OIR images, histopathologic diagnoses, and morphometric data on the lesions. To develop and validate a diagnostic algorithm: Classification: A subset (~50%) of OIR images collected will be used to complete the development of state-of-the-art image processing algorithms to extract robustly effective diagnostic features. Blind Testing and Evaluation: The algorithms established will be evaluated and validated in a prospective blind-test fashion using the complementary subset of the database that was not involved in designing the classifier. The sensitivity and specificity of the classification system will be evaluated based on the receiver-operating-characteristic (ROC) curve. To identify the pathophysiologic parameters responsible for the diagnostic optical features: The anatomic and physiologic sources of the diagnostic optical signatures will be identified by comparative analyses using the OIR images, microscopic histomorphometric techniques and theoretical modeling to test the following hypotheses: The calculated differences in hemoglobin oxygen saturation. Comparisons of the calculated size distributions of skin scattering centers with histologic and morphometric analyses of various cellular and tissue components of the skin lesions. The relative densities and distributions of the different anatomic and physiologic diagnostic features within the interrogation volumes are important diagnostic factors in OIR.

There is a significant need to develop new and more effective ways to treat melanoma that will decrease patient morbidity and mortality. This protocol intends to collect and process a portion (< 20% of any node) of lymph nodes from melanoma patients undergoing routine surgical SLN resection: the SLN(s) and 1 adjacent non-SLN(s) are planned for study. In addition, blood will be drawn at the pre study visit (serum and peripheral blood mononuclear cells) and appropriate lineage control tissue will be collected. Material only from already-indicated and planned procedures as part of standard medical care will be used. The main goal of this study will be to properly collect and process material to be analyzed and explore the molecular features melanoma biological samples.

RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer, and may help doctors learn how well patients will respond to treatment. PURPOSE: This laboratory study is looking at biomarkers to predict the response to interferon therapy in patients with melanoma.

The purpose of this study is to monitor a specific cellular immune response in melanoma patients at an early stage of the disease, that have been vaccinated with a Melan-A VLP vaccine.

This early phase I study collects blood samples and monitors the levels of pembrolizumab and nivolumab as they move through the body in patients with melanoma and/or non-small cell lung cancer. Pembrolizumab and nivolumab are a monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Studying samples of blood in the laboratory from patients receiving pembrolizumab and nivolumab may help doctors learn more about the effects of pembrolizumab and nivolumab on cells. It may also help doctors understand how well patients respond to treatment. Information from this study may be used in the future to guide physicians to make dosage adjustments based on serum concentrations of drug to minimize adverse side effects and maximize the effect of the drug.

Dermalyzer is a device intended to be used as a decision support system for assessing cutaneous lesions suspected of being melanomas. The input from the device is not intended to be used as the sole source of information for diagnosis. Intended to be used by medical professionals. The service does not provide any other diagnosis. The study is a pre-marketing, prospective, confirmatory, first in clinical setting, pivotal multi-centre, non-interventional clinical investigation to evaluate the clinical safety, performance and benefit of Dermalyzer in patients with cutaneous lesions where malignant melanoma (MM) cannot be ruled out. Primary objective: The primary objective of the investigation is to determine the diagnostic precision of the device; to answer at which level the AI tool Dermalyzer can identify malignant melanomas among cutaneous lesions that are assessed in clinical use due to any degree of malignancy suspicion. Secondary objectives: A) To evaluate usability and applicability in clinical praxis of Dermalyzer by users (medical professionals), B)To gain an increased knowledge and understanding of how digital tools enhanced co-artificial intelligence can assist physicians with the right support for an earlier diagnosis of malignant melanoma. Exploratory objective: To explore health economic aspects of improved diagnosis support Methods: The subjects will be included from around 30 primary care centers in Sweden. If the subject's lesion(s) is suspected of melanoma or melanoma cannot be ruled out, the subject is asked to participate in the investigation. The investigator examines the subject's lesion(s) and makes the clinical assessment of the subject lesion(s) based on established clinical decision algorithms The investigator takes dermoscopy images according to standard of care and archives the image(s) according to clinical routine. The investigator decides on action, based on his or her MM suspicion (excision at the primary care center or referral for excision or referral to a dermatologist for further assessment). The investigator takes images of the lesion(s) again, this time with a mobile phone, containing the AI software, connected to a dermatoscope, and follows the on-screen instructions. The image is processed by the AI and the results are visible on the screen within seconds. The investigator records how he considers that the degree of suspicion of MM (higher vs lower) would have been affected by the AI SW result if it had been the governing body for the treatment. At study follow-up, the final tumor diagnosis from the histopathology results (melanoma/non melanoma) or by dermatologist assessment (if stated as undoubtedly benign), the degree of agreement between the true final diagmosis and the outcome of the AI decision support is determined, and the diagnostic accuracy in distinguishing melanoma from non-melanoma, in terms of sensitivity and specificity as well the positive and predictive value. The corresponding comparison is performed from the examining investigators estimated clinical degree of suspicion. The clinical investigation will collect information from the users, how participating users (investigators at the site) experience the usability of the AI decision support and attaching applications, from short surveys including the validated System Usability Scale.

The investigators plan to study the ability to identify the lymph nodes beyond the sentinel lymph node that may harbor cancer using methylene blue dye.

The purpose of this study is to determine if circulating tumor cells (CTC) can be accurately detected and isolated from the blood of participants with melanoma using novel laboratory techniques. Blood samples will be collected from participants with melanoma, and also from participants with other solid tumor cancers and healthy volunteers for purposes of comparison. Relevant information will be collected from participant's medical record and stored in a coded manner in a password-protected format. This information will be used to look for correlations of research results on blood samples to participant's medical condition. Test results will not be given to participants or their physicians. In some cases, CTC may be grown for long-term cell lines for further research.

Study of late physical, psychological and social effects in patients treated with ipilimumab for advanced (stage IV or unresectable stage III) melanoma.