View clinical trials related to Dysplastic Nevi.
Filter by:The investigators' hypothesis is that cutaneous melanoma, melanoma in situ, dysplastic nevi and benign nevi all differ in not only clinical characteristics but also molecular and genotypic characteristics. Patients with suspected primary cutaneous melanoma or a differential diagnosis, or secondary melanoma can be asked to participate in the first part of the project and patients with suspected or confirmed secondary (spread) melanoma can be included in the second part of the study. Participants included in the study answer a validated questionnaire regarding epidemiological and phenotypic factors to map medical history, prior UV exposure, family history of melanoma and/or other cancer types, skin type, smoking habits, alcohol use and quality of life. Blood samples (whole blood) are collected before primary local excision and before secondary surgical procedures as well as during follow up of patients with secondary disease and oncologic treatment. During local excision of the primary pigmented skin lesion, full-thickness skin punch biopsies are taken by trained dermatologists. The biopsies, in the lesion and next to the lesion in the normal skin of the suspected melanoma, are taken, snap frozen and stored deep frozen. The primary lesions are documented by accurate imaging methods prior to excision. Tissue samples from suspected or confirmed secondary melanomas are collected mainly through surgical and core needle biopsies before, during and after treatment and in case of disease progress or treatment failure. Tissue samples are snap-frozen and stored in the same way as samples from primary melanomas. Comprehensive questionnaire based, imaging-based information, as well as histologic information provided from the pathologist report is included and stored in a secure database. All the information in the database, along with information from molecular analysis of tissue and/or blood samples will then be used to find objective, molecular and clinical differences in melanoma, melanoma in situ, dysplastic and benign nevi along with potential information of biological aggressivity of both primary and secondary melanoma in order to find more objective diagnostic markers.
Malignant melanoma (MM) is a deadly cancer, claiming globally about 160000 new cases per year and 48000 deaths at a 1:28 lifetime incidence (2016). The golden standard, dermoscopy, enables Dermatologists to diagnose with a sensitivity of 40%, and a 8-12% specificity, approximately. Additional diagnostic abilities are restricted to devices which are either unproved or experimental. A new technology of Neuronal Network Clinical Decision Support (NNCD) was developed. It uses a dermoscopic imaging device and a camera able to capture an image. The photo is transferred to a Cloud Server and further analyzed by a trained classifier. Classifier training is aimed at a high accuracy diagnosis of Dysplastic Nevi (DN), Spitz Nevi and Malignant Melanoma detection with assistance from a Deep Neuronal Learning network (DLN). Diagnosis output is an excise or do not excise recommendation for pigmented skin lesions. A total of 80 subjects already referred to biopsy pigmented skin lesions will be examined by dermoscopy imaging in a non interventional study. Artificial Intelligence output results, as measured by 2 different dermoscopes, to be compared to ground truth biopsies, by either classifier decisions or a novel Modified Classifier Technology output decisions. Primary endpoints are sensitivity and specificity detection of the NNCD techniques. Secondary endpoints are the positive and negative prediction ratios of NNCD techniques.
Non-interventional study to evaluate the utility of removing Dysplastic Nevi with a defined 2 mm margin.
The purpose of the potential research study participant registry is to keep potential research subjects informed about any future research studies in which they may meet the criteria for enrollment. The purpose of this study is also to assist current and future clinical trials with recruitment of subjects.
During the course of a case-control study of melanoma conducted at the Bufalini Hospital, Cesena, Italy in the years 1994-1996, 20 families with 2 or 3 melanoma cases were identified and studied. The area where the study was conducted showed the steepest increase in melanoma incidence in Mediterranean populations between the years 1987 and 1997. Clinical characteristics of melanoma in the families studied were similar to those typically described in fair-skinned populations, but no relevant mutations in the coding regions of known candidate genes from melanoma have been found. Lack of findings could be due to the modest number of families and the small number of affected CMM cases examined. We cannot exclude the possibility of alterations in introns, splicing sites or promoter regions. Also epigenetic factors could affect the expression of the gene products we studied. Alternatively, germline alterations of a gene(s) other than the candidate genes we analyzed may play an important role in melanoma predisposition in this population. A large number of families is needed to test these hypotheses. These additional families could provide an important contribution to the understanding o melanoma development. In fact, this population does not generally have the host characteristics that are usually associated with higher risk for melanoma (e.g., light skin color, red hair, blue eyes, multiple freckles, tendency to sunburn, etc.) but do have a relative high frequency of dysplastic nevi and melanoma. The main objective of this study is to recruit more families at the Bufalini Hospital, Cesena, Italy in order to reach a larger sample size. Recently, 16 potential melanoma-prone families have been identified through patient's or physicians' referrals by the Dermatologists at the Bufalini Hospital. The dermatologists have maintained close relationships with members of these families and are confident that these subjects would be willing to participate in a study if contacted. The first goal of our study is to contact this family group and verify their willingness to participate in the study. In addition, new families could be identified and recruited. We propose to conduct a pilot project. We estimate recruitment of approximately 25 families with 2 or more melanoma cases in first -degree relatives over a one-year period, including the 16 families already identified and approximately 10 new kindreds. At the end of the pilot phase we will determine the feasibility of continuing recruitment.