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Nevus, Pigmented clinical trials

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NCT ID: NCT03767439 Withdrawn - Clinical trials for Basal Cell Nevus Syndrome

Nivolumab With Vismodegib in Patients With Basal Cell Nevus Syndrome

Start date: July 2019
Phase: Phase 2
Study type: Interventional

This is a single-arm, phase II study to assess the efficacy of combined SMO and PD-1 inhibition with Vismodegib (SMO inhibitor) and Nivolumab (anti-PD-1 antibody) in BCNS patients (target enrollment of 22 patients), with a primary endpoint of 18-month disease control rate. The purpose of this study is to test the hypothesis that Nivolumab and Vismodegib will improve the percentage of BCNS patients who achieve disease control (defined as total tumor burden <50% of baseline) at 18 months from 50% to 80%. Baseline and on-treatment biopsies will be obtained to characterize the immune effects of combined SMO and PD-1 inhibition.

NCT ID: NCT03703310 Completed - Clinical trials for Basal Cell Nevus Syndrome

Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome (Gorlin Syndrome)

Start date: February 19, 2019
Phase: Phase 3
Study type: Interventional

This is a global, multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with Gorlin syndrome. Participants will be required to apply the investigational product for 12 months. The primary endpoint is a comparison between the two treatment arms of the number of new BCCs that develop over the 12 month period.

NCT ID: NCT03699995 Recruiting - Cutaneous Melanoma Clinical Trials

MoleMapper, Visiomed, and Confocal Microscopy in Screening Participants for Melanoma

Start date: May 18, 2018
Phase: N/A
Study type: Interventional

This trial studies how well MoleMapper, Visiomed, and confocal microscopy work in screening participants for melanoma. Analyzing images (photographs) made with three different portable imaging systems may be as good as a visit to a dermatologist's office for finding melanomas before they can spread.

NCT ID: NCT03208296 Suspended - Clinical trials for Basal Cell Carcinoma in Basal Cell Nevus Syndrome

Study of ASN-002 to Treat Basal Cell Carcinomas (BCCs) in Individuals With Basal Cell Nevus Syndrome (BCNS)

Start date: December 1, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective is to confirm the safety of treating multiple BCCs once weekly x 3 weeks in individuals with Basal Cell Nevus Syndrome (BCNS). The secondary objectives of the study are to obtain preliminary data on the effectiveness of ASN-002 in the treatment of BCCs in individuals with Basal Cell Nevus Syndrome (BCNS) by 1. evaluating the histological clearance of BCCs in patients with BCNS, and 2. assessing the clinical changes of BCCs after treatment with ASN-002, and 3. assessing the systemic effect of ASN-002 by determining response in non-injected lesions 4. assess the safety and clinical changes after a second cycle of ASN-002 injections

NCT ID: NCT03054584 Recruiting - Melanocytic Nevi Clinical Trials

Genetic Basis of Melanocytic Nevi

Start date: June 26, 2017
Phase:
Study type: Observational

The objective of this protocol is to further elucidate the genetic mutations that drive melanocytic nevi (benign melanocytic neoplasms, moles). This will be performed by whole genome, whole exome, or targeted sequencing of de-identified specimens. Herein, the investigators plan to isolate DNA from de-identified skin biopsy specimens and blood samples: 1. From melanocytic nevi collected by skin biopsy (a shave or punch biopsy). A part of the tissue will be submitted for routine diagnostic dermatopathology and investigational histomorphologic and immunohistochemical analysis. 2. From corresponding normal tissue (blood). DNA isolated from blood will be used as a normal control when analyzing sequencing data to identify somatic mutations in lesional tissue.

NCT ID: NCT02473874 Withdrawn - Melanocytic Nevus Clinical Trials

Comparison Imaging System Between Spatially Modulated Quantitative Spectroscopy and Skin Spect Dermoscopy

Start date: June 2015
Phase:
Study type: Observational

The purpose of this study is to obtain skin spectroscopic data from two imaging systems. Comparison groups: - Skin Spect dermoscope - Spatially modulated quantitative spectrometer

NCT ID: NCT02280889 Recruiting - Quality of Life Clinical Trials

Quality of Life and Stigmatization in Children With Congenital Melanocytic Nevi Before and After Nevus Excision

Start date: May 2013
Phase:
Study type: Observational

Congenital melanocytic nevi (CMN) are a quite common congenital disorder. Over years, surgical excision was proposed to the patients because transformation into a malignant skin tumor (melanoma) was feared. Recent data proof that the risk for malignancy was overestimated. Nowadays still a lot of patients express their wish for surgical removal out of aesthetic reasons and psychological impacts. Many patients and families experience stigmatization because of the nevus. To proof a medical indication for surgical removal the investigators want to evaluate the quality of life and stigmatization before and after nevus surgery.

NCT ID: NCT02157623 Completed - Clinical trials for Basal Cell Nevus Syndrome

Blue vs Red Light During Levulan Based Photodynamic Therapy in Patients With Basal Cell Nevus Syndrome

Start date: February 1, 2016
Phase: N/A
Study type: Interventional

The investigators will be testing whether aminolevulinate-based (Levulan™) Photodynamic Therapy (PDT) shows effectiveness in the treatment and prevention of cutaneous basal cell carcinoma (BCC) in Basal Cell Nevus Syndrome (BCNS) patients. Levulan™ PDT is an FDA-approved method widely used currently for squamous precancers of the skin. The investigators hypothesize that PDT will provide exceptional benefit in the BCNS population because PDT is nonmutagenic, nonscarring, and can be safely repeated many times. Additionally, the study will investigate whether there are any differences in tumor clearance between the Blu-U® (blue lamp) and Aktilite™(red lamp) therapies.

NCT ID: NCT02100371 Completed - Clinical trials for Basal Cell Nevus Syndrome

Study of BMS-833923 in Two Specific Patients With Basal Cell Nevus Syndrome

Start date: February 2014
Phase: N/A
Study type: Interventional

This is an extension study of Protocol CA194002 to allow 2 specific participants with basal cell nevus syndrome in the CA194002 study at Princess Margaret Cancer Centre who are still benefitting from the study drug BMS-833923 to continue receiving the study drug. This study will continue to evaluate the safety and tolerability of BMS-833923 in these participants.

NCT ID: NCT01444560 Completed - Cutaneous Melanoma Clinical Trials

miRNA Machinery in Melanoma, Melanoma Metastases and Benign Melanocytic Naevi

Start date: December 2008
Phase: N/A
Study type: Observational

MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length, capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of complementarity. miRNAs have recently been shown to play pivotal roles in diverse developmental and cellular processes and linked to a variety of skin diseases and cancers. In the present study, the investigators examines the expression profiles of miRNA machinery components such as miRNA maturation and transport factors, microprocessor complex and RISC subunits in cutaneous melanoma, cutaneous melanoma metastases and benign melanocytic nevi.