NCT05402059

Clinical Outcomes and Biomarkers in Patients With Stage 0-IV Melanoma in Real Clinical Practice

prospectIve Non-interventional Study of Clinical Outcomes And Biomarkers in Patients With Stage 0-IV mElanoma in reaL clinicaL prActice

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,570 (estimated)
• Sponsor: MelanomaPRO, Russia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective non-interventional study of clinical outcomes and biomarkers in patients with stage 0-IV skin melanoma in real clinical practice

Detailed description

Most oncology experts now recognize that the most effective and safest treatment options should be considered for first-line therapy. Since the planned use of drugs, including dosing, treatment interruption and early discontinuation of treatment, in clinical practice may differ from the procedures used in clinical trials, post-marketing "real world" data are important to quantify the feasibility, acceptability, and practical considerations for prescribing targeted and immunotherapy. Therefore, for the clinical and scientific communities, it is of great interest to evaluate the choice of the patient and the method of treatment used in the daily practice of oncological centers in Russia. Moreover, the available data imply an association between PDl-1 expression and other biomarkers in tumors and the efficacy of drug therapy. The purpose of this study is to evaluate clinical outcomes in patients with stage 0-IV skin melanoma in real clinical practice in the context of different levels of PDl-1 expression in the tumor and other potential biomarkers. In addition, it is of interest to gain insight into the real-world data on the quality of life of melanoma patients treated for metastatic disease. It is well known, that the prognosis of patients with stage 0-IV melanoma is too heterogeneous, therefore, in this study, distinguish several cohorts will be organised.

Conditions

• Melanoma
• Melanoma (Skin)
• Melanoma, Uveal
• Melanoma Stage IV
• Melanoma Stage III
• Melanoma, Stage II
• Melanoma in Situ
• Melanoma, Ocular

Interventions

Type	Name	Description
DRUG	surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines	Any kind of treatment or observation (no treatment) initiated or planned in accordance with current clinical practice

Timeline

• Start date: 2022-03-02
• Primary completion: 2024-04-01
• Completion: 2025-04-01
• First posted: 2022-06-02
• Last updated: 2022-06-15

Locations

1 site across 1 country: Russia