Establishment and Standardization of a Platform for In-depth Tumour Profiling (TUPRO) in Patients With Advanced Melanoma - a Prospective, Multicentric HFV Research Project/Category A

Sample Processing and Report Generation

时间窗: through study completion, an average of 1 year

* 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)

Classification of proposed treatment options (according to the one of the 7 categories below)

时间窗: through study completion, an average of 1 year

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)

Classification of Tumour Board's recommendations according to ESCAT (categories below)

时间窗: through study completion, an average of 1 year

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)

时间窗: through study completion, at least 6 month of follow up

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

Time to first subsequent treatment (TTFST) ratio

时间窗: through study completion, at least 6 month of follow up

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

Toxicity

时间窗: through study completion, at least 6 month of follow up

\- Frequency (proportion) of patients terminating treatment due to toxicity

Survival

时间窗: through study completion, at least 6 month of follow up

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

Event free survival

时间窗: through study completion, at least 6 month of follow up

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

Radiological tumour response

时间窗: through study completion, at least 6 month of follow up

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

Sample Processing and Report Generation (Tumor Biopsy, peripheral blood sample and stool sample)

时间窗: through study completion, an average of 1 year

* 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)