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Melanoma (Skin) clinical trials

View clinical trials related to Melanoma (Skin).

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NCT ID: NCT06299878 Recruiting - Melanoma Stage Iii Clinical Trials

MelPRO-0322 (CRISTINA Trial) [miCrobiome pRedIctS aPD1 effecTivnes In melaNoma pAtietns]

CRISTINA
Start date: January 1, 2022
Phase:
Study type: Observational

The goal of this observational study is to learn about if new biomarkers such as gut microbiota and molecular genetics melanoma features could predict clinical radiological and pathological response to neoadjuvant monotherapy with anti-PD1 agents in patients with resectable stage IIIB-D melanoma. The main questions it aims to answer are: - radiological and pathological response rate to three doses of antiPD1 agents; - do radiological and pathological responses correlate with gut microbiota and melanoma molecular genetics features Participants will receive three doses of aPD1 monotherapy as per center routine practice and will undergo regional lymphadenectomy. Before treatment initiation patients will be asked to bring faeces probes and fill out dietary questionnaire as well as just before the surgery. After sugery adjuvant therapy will be prescribed for 12 month and patients will be followed up according to institutional routine practice for 5 years.

NCT ID: NCT06254547 Recruiting - Melanoma (Skin) Clinical Trials

Leaderboard Influence on Self-Regulated Training in a Gamified Dermoscopy Training App

Start date: January 27, 2024
Phase: N/A
Study type: Interventional

This study aims to examine the isolated effect of leaderboards (scoreboards) and daily training motivation on dermatology skill acquisition and training engagement within a gamified dermoscopy training platform. Research Questions: What is the effect of leaderboards and/or daily motivation on diagnostic accuracy? What is the effect of leaderboards and/or daily motivation on self-regulated learning: time spent training and case amount? What is the effect of leaderboards and/or daily motivation on training distribution? Method: 150 danish medical students will upon inclusion and end of trial answer a Multiple Choice Questionnaire (MCQ). Participants will be asked to download the gamified training platform onto their mobile devices. Within the app participants can access quizzes on a library of 10,000+ skin lesions combined with written educational modules on histopathological skin diagnosis. Participants receive instant feedback on quiz answered. Points are awarded for correct answers and removed for incorrect answers. Participants will be randomized to one of three groups; either receiving no communication from the principal investigator, receiving a daily motivational message, or receiving a once daily updated leaderboard ranking participant's scores. The intervention will last for seven days, followed by a 14-day washout period.

NCT ID: NCT06221397 Recruiting - Melanoma Clinical Trials

Clinical Validation Study of an AI-based CAD System for Early Non-Invasive Detection of Cutaneous Melanoma

LEGIT_MC_EVCDA
Start date: September 17, 2020
Phase:
Study type: Observational [Patient Registry]

The goal of this Cross-sectional analytical observational study of clinical case series is to validate a Computer-aided diagnosis software developed by AI Labs Group for the identification of cutaneous melanoma in images of lesions taken with a dermatoscopic camera. This study will be carried out in patients with skin lesions with suspected malignancy seen at the Dermatology Department of the Cruces University Hospital and Basurto University Hospital. The main questions it aims to answer are: - If the AI algorithm developed by AI Labs group is a valid tool to identify cutaneous melanoma in dermoscopic images with high reliability. - Comparing the device's performance with dermatologists, with primary care physicians' assessment to be considered in later phases. - Assessing the utility and feasibility of the device in adverse environments with technical limitations. In this way, patients with skin lesions with suspected malignancy seen at the Dermatology Department of the Cruces and Basurto University Hospitals will be recruited. Patients in this study will not receive any specific treatment as part of the research protocol. In addition, they will continue their regular prescribed medications and treatments as directed by their primary healthcare providers. This study does not require doing a follow-up of the subjects. Every patient only gets their skin lesions photographed at the time of visit.

NCT ID: NCT05940311 Recruiting - Melanoma (Skin) Clinical Trials

Versatile Ampification Single-Molecule Detection in Liquid Biopsy

VerSiLiB
Start date: April 12, 2022
Phase:
Study type: Observational [Patient Registry]

Robust detection of single molecules in complex biological fluids is the ultimate goal in the field of disease biomarker analysis. Conventionally, to enable the quantitative analysis of individual molecules in macroscopic volumes, analyte pre-concentration and sample partitioning into fL-nL compartments has been combined with the amplification of the specific recognition events. In these setups, the positive or negative detection of fluorescence signal is triggered by enzymatic reactions occurring in each compartment. Binary readout based on Poisson statistics quantifies ultra-low concentrations of analyte molecules. This approach has been adopted for nucleic acids analysis in current digital PCR, and is also available for proteins in a technique coined as digital ELISA. The objective of VerSiLiB is to develop an enzyme-free amplification strategy for the analysis of both protein and nucleic acid analytes with the single digital platform that offers means to access additional information on target analytes not achievable with current technologies. Method is based on novel affinity-mediated-transport amplification, where affinity interaction of target analyte with a specific ligand attached to a magnetic nanoparticle transporter is accompanied with rapid shuttling of fluorescent tracers that serve as reporters. By applying external magnetic field, tracers are transported from the tracer storage side (where they are dark) to tracer active side (where they become bright) only if target analyte is present in the small reaction compartment. Tailored plasmonic nanostructures will be prepared at the storage and active sides of the compartment to render the tracer either dark or bright. The aim is to perform technology validation for the novel VerSiLiB proteogenomics amplification platform in cancer management using biobanked liquid biopsy samples.

NCT ID: NCT05906277 Recruiting - Melanoma (Skin) Clinical Trials

Biobanking and New Biomolecular Metrics

Melamoma4p
Start date: January 29, 2019
Phase: N/A
Study type: Interventional

The goal of this Interventional study aims to apply, in our Institutes, a 4p oncological model i.e. predictive, personalized, of precision and participated (Regina Elena and San Gallicano).

NCT ID: NCT05786924 Recruiting - Colorectal Cancer Clinical Trials

A Study of BDTX-4933 in Patients With KRAS, BRAF and Select RAS/MAPK Mutation-Positive Cancers

Start date: April 18, 2023
Phase: Phase 1
Study type: Interventional

BDTX-4933-101 is a first-in-human, open-label, Phase 1 dose escalation and an expansion cohort study designed to evaluate the safety and tolerability, maximum tolerated dose (MTD) and the preliminary recommended Phase 2 dose (RP2D), and antitumor activity of BDTX-4933. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced/metastatic non-small cell lung cancer (NSCLC) harboring KRAS non-G12C mutations or BRAF mutations, advanced/metastatic melanoma harboring BRAF or NRAS mutations, histiocytic neoplasms harboring BRAF or NRAS mutations, and other solid tumors harboring BRAF mutations. The study population for the Dose Expansion part of the study comprises adults with recurrent advanced/metastatic NSCLC harboring KRAS non-G12C mutations. All patients will self-administer BDTX-4933 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.

NCT ID: NCT05751928 Recruiting - Melanoma (Skin) Clinical Trials

A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma

NEO-MIMAJOR
Start date: March 2023
Phase: Phase 3
Study type: Interventional

This study is an open-label, randomized, comparative phase III study, which will include subjects with resectable stage III skin melanoma (up to 3 resectable transient metastases are acceptable).

NCT ID: NCT05732805 Recruiting - Melanoma Clinical Trials

A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma

OCTAVA
Start date: August 2, 2022
Phase: Phase 3
Study type: Interventional

The aim of study is to investigate the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of BCD-217 followed by prolgolimab monotherapy versus prolgolimab monotherapy as first-line therapy in subjects with unresectable or metastatic melanoma.

NCT ID: NCT05704647 Recruiting - Melanoma (Skin) Clinical Trials

Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases

Start date: February 23, 2023
Phase: Phase 2
Study type: Interventional

To learn if giving nivolumab in combination with relatlimab can help to control melanoma that has spread to the brain (melanoma with brain metastases). The safety and side effects of the study drug combination will also be studied.

NCT ID: NCT05655312 Recruiting - Melanoma (Skin) Clinical Trials

MC1R-targeted Alpha-particle Therapy Trial in Adults With Advanced Melanoma

Start date: June 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

In this first-in human, phase I/IIa study, the safety and efficacy of [212Pb]VMT01, an alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor (MC1R) is being evaluated in patients with unresectable and metastatic melanoma.