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Melanoma clinical trials

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NCT ID: NCT05432622 Completed - Melanoma Clinical Trials

A Study of Treatment Patterns and Outcomes in Participants With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy

Start date: December 19, 2019
Phase:
Study type: Observational

The purpose of this study is to examine real-world data among participants with stage IIIa melanoma initiating nivolumab as adjuvant treatment in the community practice setting by utilizing patient data from the United States Oncology Network (USON) iKnowMed (iKM) electronic health records (EHR) database.

NCT ID: NCT05426239 Completed - Advanced Melanoma Clinical Trials

Treatment Patterns and Outcomes in Participants With Advanced Melanoma in Germany Using a German Database

Start date: January 9, 2019
Phase:
Study type: Observational

This study is a non-interventional retrospective observational study performed on secondary data from a German multi-site cohort registry, the German national registry of skin cancer (ADOReg).

NCT ID: NCT05389085 Completed - Malignant Melanoma Clinical Trials

Fast Track Diagnosis of Skin Cancer by Advanced Imaging Technologies and Tumour Tapestripping

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

In this clinical feasibility study the investigators will test and compare two advanced optical imaging technologies, lipid and RNA tape stripping with regards to diagnostic accuracies for fast bedside diagnosis of pigmented skin tumours.

NCT ID: NCT05367180 Completed - Melanoma Clinical Trials

The Impact of a Prevention Program on Sun Risks in Primary School in Tropical French Region

PRESOLRE
Start date: August 31, 2022
Phase: N/A
Study type: Interventional

Sun exposure during childhood can cause the development of skin cancer in later years, in particular melanoma, which is the most lethal.The worldwide incidence of melanoma is on the rise, with nearly 290,000 new cases diagnosed in 2018. The country with the highest age-standardized incidence rate is Australia, where 40.4 cases per 100,000 men and 27.5 cases per 100,000 women were reported in 2018. Since 2008, however, this incidence has decreased by 11% in the 14-49 age group following the implementation of effective sun safety campaigns. In the French overseas department of Reunion Island, which is characterized by a great diversity of skin phototypes due to multiple migratory flows, the ultraviolet (UV) index is very high - equivalent to that in Australia. The age-standardized incidence rate of melanoma Reunion Island increased fourfold between 1995 and 2015. In 2015, it was estimated at nearly 30.0 new cases per 100,000 inhabitants in people with skin phototypes I-III, compared to 13.5 in metropolitan France. Over the course of a lifetime, 80% of exposure to UV radiation and 50% of skin damage occur before the age of 21, mainly in the school environment. In spite of this, knowledge of the risks associated with sun exposure remains insufficient among children and adolescents. Similar quantitative data have been reported for Reunion Island by the local association MiSolRé (Mission Soleil Réunion), which has been running sun safety campaigns in elementary schools since 2017. However, methodological limitations compromise the validity and extrapolation of the results. And the question arises as to the type of programme to be implemented: strengthening individual skills through health education methods? Community reinforcement through training activities involving peers? Improving access to prevention? Thus, it seems necessary to rigorously evaluate the effectiveness of different actions such as the educational programme "Vivre avec le soleil" alone or associated with the visit of professionals in the field with or without distribution of photoprotection material. The aim of this randomized controlled trial is to evaluate the effectiveness of three awareness-raising programmes on the risks linked to sun exposure, delivered in primary school classes in Reunion Island, on the pupils' knowledge of sun prevention.

NCT ID: NCT05297565 Completed - Melanoma Clinical Trials

A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection

CheckMate-6GE
Start date: August 3, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.

NCT ID: NCT05260684 Completed - Melanoma Clinical Trials

Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US

OCEANMIST
Start date: January 17, 2022
Phase:
Study type: Observational

This study aims to compare real-world effectiveness of BRAF/MEK inhibitors in BRAF-mutant metastatic melanoma patients in the United States by line of therapy. The Flatiron Health electronic health record (EHR) data from US cancer clinics will be used for this retrospective database analysis.

NCT ID: NCT05217303 Completed - Melanoma Clinical Trials

HL-085 in NRAS-mutated Advanced Melanoma

Start date: November 2, 2020
Phase: Phase 2
Study type: Interventional

This was an open-label, single-arm, multi-center phase II clinical study, aimed at investigating the efficacy and safety of HL-085 capsule in the treatment of advanced melanoma patients with NRAS mutation.

NCT ID: NCT05172232 Completed - Malignant Melanoma Clinical Trials

Diagnostic Precision of the AI Tool Dermalyzer to Identify Malignant Melanomas in Subjects Seeking Primary Care for Melanoma-suspected Cutaneous Lesions

AI-DSMM
Start date: May 2, 2022
Phase:
Study type: Observational

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.

NCT ID: NCT05116202 Completed - Melanoma Clinical Trials

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)

Start date: February 2, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of treatment combinations in cancer immunotherapy (CIT)-naive participants with resectable Stage III melanoma (Cohort 1) and in participants with Stage IV melanoma (Cohort 2). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population.

NCT ID: NCT05115006 Completed - Melanoma Clinical Trials

A Study of Adjuvant Melanoma Stakeholder Treatment Preferences

Start date: January 7, 2021
Phase:
Study type: Observational

The purpose of this study is to understand the trade-offs that participants with surgically treated melanoma would be willing to make among key features and outcomes of adjuvant anti-cancer treatments or no adjuvant treatment / observation.