National Cohort Study of Patients With Resectable or Unresectable Advanced Melanoma Including Stage II, III, or IV and Primary Melanoma Collecting Clinical, Biological, and Treatment Data Over 10 Years

What this Trial Is About

Melanoma is a rare but increasingly common cancer in France, with a high mortality rate despite prevention efforts. Metastatic melanoma is a complex disease driven by multiple mutations and resistant to conventional treatments. Since 2011, therapies like anti-CTLA4 and anti-PD1 antibodies, along with BRAF and MEK inhibitors, have shown survival benefits. This research aims to build a national cohort called MELBASE to study advanced melanoma patients, collecting clinical, biological, and economic data to identify new prognostic and predictive factors and improve future treatment strategies. The study enrolls patients with resectable stage II or III melanoma since June 2023 and those with unresectable stage III or IV melanoma or unresectable primary melanoma since March 2013. The project includes collecting biological samples such as tumor tissue and blood components at inclusion and during disease progression. Quality of life questionnaires are also administered regularly. This observational cohort follows patients for up to 10 years, gathering comprehensive clinical and treatment data across multiple French centers. Participants undergo regular evaluations including clinical exams, tumor genotyping, imaging, and quality of life assessments. Data collected include tumor characteristics, treatment responses, side effects, health economics, and survival outcomes. Optional biobanking of tumor and blood samples supports biological research. The primary outcome measure is overall survival over 10 years. Secondary measures include progression-free survival, treatment response, and safety. This long-term monitoring provides valuable insights into melanoma progression and treatment impact.

Follow-up of a National Cohort of Melanoma Resectable Stage II, Stage III or IV Patients or Unresectable Primary