Establishment and Standardization of a Platform for In-depth Tumour Profiling (TUPRO) in Patients With Melanoma

• Number of samples (with sufficient material and quality) made available for intended analysis per technology
• Number of molecular summary reports (generated from the translational domain) that could be made available to the Tumour Board
• Number (proportion) of cases in which the Tumour Board considers the molecular summary report as useful for making a treatment recommendation on a scale from zero (not useful at all) to five (very useful).
• Number (proportion) of cases in which the treating physician considers the Tumour Board's recommendation as useful for making a treatment decision on a scale from zero (not useful at all) to five (very useful)
• Types of molecular information and combinations of molecular information from the biotechnology domain that the pre-Tumour Board considers as useful for making a treatment recommendation beyond routine diagnostics (incl. routine pathology and NGS testing)

Select one of the following categories:

• On-label treatment with molecular matched treatment (SwissMedic label as reference) +/- radiotherapy or chemotherapy;
• Treatment with classical chemotherapy +/- radiotherapy (on label if label available);
• Referral to a suitable clinical trial;
• Off-label treatment (SwissMedic label as reference) with molecular matched treatment or immunotherapy +/- radiotherapy or chemotherapy;
• Off-label treatment (authorization in countries with comparable control systems for medicinal products as defined by SwissMedic) with molecular matched treatment or immunotherapy +/- radiotherapy or chemotherapy;
• Immunotherapy
• No active anti-tumour treatment (best supportive care)

Select one of the categories below:

• I-A: prospective, randomised clinical trials show the alteration-drug match in a specific tumour type results in a clinically meaningful improvement of a survival end point
• II-A: retrospective studies show patients with the specific alteration in a specific tumour type experience clinically meaningful benefit with matched drug com pared with alteration-negative patients
• III-A: clinical benefit demonstrated in patients with the specific alteration (as tiers I and II above) but in a different tumour type. Limited/absence of clinical evidence available for the patient-specific cancer type or broadly across cancer types
• IV-A: evidence that the alteration or a functionally similar alteration influences drug sensitivity in preclinical in vitro or in vivo models
• X: No evidence that the genomic alteration is therapeutically actionable

• Time to first subsequent treatment (TTFST), incl. best supportive care

• Time to first subsequent treatment (TTFST) ratio (TTFST 2 / TTFST 1: TTFST 2 = TTFST on current project; TTFST 1 = TTFST on previous treatment [before entering the project])

• Frequency (proportion) of patients terminating treatment due to toxicity

• Overall survival (OS), calculated from registration until death due to any cause

• Event free survival (EFS), defined as time to treatment failure or death

• Proportion of patients with a radiological tumour response (CR / PR) according to local standards and trial protocol (in case of referral or trial)

• Quality of Life using the Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7) questionnaire should be assessed during regular data collection (optional).

Score range: 0-28. The higher the score, the better the Quality of life (QoL).