View clinical trials related to Skin Neoplasms.
Filter by:The purpose of the study is to see if the combination of radiation therapy and cemiplimab immunotherapy is an effective treatment for people with locally advanced, unresectable CSCC.
This is a phase I, open label study employing diphencyprone (DPCP) to characterize gene expression changes of various immune cell and tumor markers in cutaneous metastases treated with topical DPCP twice weekly for 12 weeks in combination with PD-1 or PD-L1 immune checkpoint inhibition (ICI), compared to pre-treatment cutaneous metastases and to describe the adverse events associated with DPCP when administered topically twice weekly for 12 weeks in combination with PD-1 or PD-L1 ICI.
Background: Oral hedgehog inhibitors vismodegib and sonidegib have been used for the treatment of locally advanced (laBCC), metastatic basal cell carcinoma (mBCC) and in basal cell nevus syndrome (BCNS) patients. In the Netherlands, targeted therapy with vismodegib and sonidegib has been available since 2013 and 2021, respectively. No direct comparative studies have been performed between the two oral hedgehog inhibitors (HHI) vismodegib and sonidegib yet . In addition, data for sonidegib are not yet available. Objective: The aim of this study is 1) to evaluate the effectiveness of oral HHIs in the treatment of laBCC, mBCC and BCNS patients and 2) to compare the oral HHIs vismodegib and sonidegib. Study design: prospective registration study that includes all patients, regardless of age and gender, with histologically proven basal cell carcinoma receiving treatment with either vismodegib or sonidegib in the Netherlands. Patient, tumor and treatment information was gathered from patient records. Main study parameters/endpoints: The primary outcome for measuring efficacy/tumor response was median progression free survival (PFS) where the decrease, stagnation or increase in tumor size is measured by maximum diameter. Secondary outcomes are frequency, severity and reversibility of treatment-emergent adverse events and disease-specific quality of life expressed as mean scores on the EORTC-QLQ-C30 and aBCCdex questionnaires.
Hypothesis: More than 80% of the participants (n=40) will complete the intervention at three month (intervention completion) and the six month follow-up (retention rate as feasibility). More than 70% of the participants will report high overall study satisfaction (acceptability) with the intervention and study. This pre-pilot will inform intervention and procedural refinements for the pilot. Hypothesis: Participants who receive the intervention (n=57) will report more skin cancer-related preventive behaviors (e.g., mean of summed score of sun protection behaviors such as use of sunscreen, etc.) at three month and six month follow-up compared to those in the control condition (n=57, who will receive general information about physical activity and nutrition).
This phase I trial finds out the side effects and possible benefits of stereotactic radiosurgery and immune checkpoint inhibitors with NovoTTF-100M for the treating of melanoma that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. It is used to treat brain tumors and other brain disorders that cannot be treated by regular surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. NovoTTF-100M is a portable battery operated device which produces tumor treating fields in the body by means of surface electrodes placed on the skin. Tumor treating fields are low intensity, intermediate frequency electric fields that pulse through the skin to disrupt cancer cells' ability to divide. Giving stereotactic radiosurgery and immune checkpoint inhibitors with NovoTTF-100M may work better than stereotactic radiosurgery and immune checkpoint inhibitors.
This project aims to validate ex vivo the use of the OCTAV® prototype integrating the "dermoscope" function before an in vivo application, by comparing images obtained by the OCTAV® prototype integrating the "dermoscope" function with the histological sections of a skin tumor excision corresponding to them exactly, at the same level.
Phase II, open label, multicentric, proof-of-principle basket trial in patients with malignant tumors of the skin amenable to intratumoral injection, and in a curative or neoadjuvant or palliative intention.
This is a new protocol to analyze how the use of the Sklip System enables laypersons to safely triage self-selected pigmented skin lesions of concern (PSLCs) from home with the same or better accuracy than pre-specified performance goals for the detection of PSLCs that require biopsy (Melanoma and atypical melanocytic nevi with uncertain malignant, Squamous cell carcinoma, Basal cell carcinoma). The study protocol will also compare the accuracy of the Sklip System when used by a layperson (Participant) versus near-perfect Sklip System user (Study Coordinator), assess whether Sklip System improves triage of PSLCs < 6 mm in diameter and triage of thin melanomas with <0.8 mm Breslow depth as suspicious, as compared to the current medical provider virtual triage method that relies on store-and-forward of smartphone clinical images (SCI), and assess accuracy of layperson-performed self-skin-exams (SSEs) at-home in the identification of all suspicious PSLCs present on their body as compared to the same layperson (Participant) evaluated with a full body skin examination (FBSE) by a dermatology Provider (DP) in-person.
Dermatological surgeons and patients routinely notice alterations in nasal shape and size following surgery and reconstruction. There is no uniform approach to objectively measure these changes. Anthropometric measurements are routinely used in rhinoplasty to assess outcomes, but they are time consuming and have not been reported as being used by dermatological surgeons. Soft-tissue measurements in profile photographs have been demonstrated to be useful for objective measurement of nasal change following surgery. This is a follow up study of the pilot study to assess the feasibility of photographic rhinometry as an objective tool, and (ii) to quantify changes following common dermatological surgical procedures on the nose. This follow-up study will aim to recruit a larger population sample to better quantify some of the changes occurring post-operatively.
Solid organ transplant recipients (OTRs) receive lifelong immunosuppressive therapy, which puts them at increased risk of cutaneous and mucosal cancers. In particular, OTRs have increased risk of skin cancer and cancers caused by human papillomavirus (HPV), including cervical cancer and oropharyngeal cancer. There is currently limited knowledge on risk factors for HPV infection and skin cancer in OTRs, and limited knowledge on the natural history of HPV infection and cervical neoplasia in OTRs compared with immunocompetent controls. With a continuously increasing number of OTRs, there is a growing need to improve our understanding of the long-term reactions to immunosuppression. The overall aim of this study is to investigate long term effects of immunosuppression on cutaneous and mucosal epithelium in Danish OTRs, including the risk of skin dysplasia and skin cancer, cervical and oral HPV infection and HPV-related dysplasia and cancer in OTRs. This study will be designed as a prospective observational cohort study based on clinical data and data from nationwide Danish registries. A total of 600 female OTRs, 600 male OTRs and 600 female controls will be included from Danish dermatology departments. The study aims to provide knowledge relevant for improving prevention of skin- and HPV-related cancers in OTRs, including personalized screening recommendations according to individual patient risk.