Active clinical trials for "Dysplastic Nevus Syndrome"

The purpose of this clinical study is to evaluate if the DermaSense prototype EIS scanner can provide medical decision support which can complement dermoscopy-based identification of the disease at time of biopsy decision.

PanFAM-1 is a clinical study for early detection of pancreatic cancer in high-risk groups. The goals of the study are to assess the performance and diagnostic accuracy of the IMMray™ PanCan-d test compared to standard-of-care imaging.

100 subjects who have a family history of pancreatic cancer (PC), or known genetic syndromes associated with increased risk of pancreatic cancer, will be followed for five years. This data will be used to determine the pancreatic cancer and precancerous lesion detection rate in High Risk Individuals (HRIs). Subjects may agree to annual imaging and annual biomarkers or to biomarkers only.

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.

A novel infrared imaging tool to aid in the clinical detection of atypical pigmented lesions and melanoma is developed. Goals include evaluation of the utility of high-resolution infrared scanning of cutaneous lesions in the diagnosis of pigmented lesions and the identification of high-risk lesions and melanomas.

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.

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.

The investigators' goal is to identify the mutation in the gene that is responsible for the development of segmental dysplastic nevi. To identify the gene the investigators may use a candidate gene approach (i.e. sequence specific genes that are thought to be involved: NRAS, BRAF, etc) or a genome-wide approach trying to implicate regions in the genome (Loss-of-heterozygosity or copy number changes on comparative genomic hybridization).