Establishment and Standardization of a Platform for In-depth Tumour Profiling (TUPRO) in Patients With Melanoma
NCT Number: NCT06463509
Acronym: TUPRO
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Melanoma
Interventions: OTHER: Establishment of an in-deepth tumor profiling platform
Sponsor: Reinhard Dummer
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 116
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-01-08
Completion Date: 2023-05-31
Locations: Department of Dermatology, University Hospital Zurich, Zurich, 8091, Switzerland

Summary:
TUPRO-Melanoma is the first project of the Tumour Profiler (TUPRO) research collaboration, which in the long-term aims to generate data that will help to understand and report the individual tumour biology and the clinical parameters for patients with advanced malignancies using innovative molecular technologies and computational analyses for in-depth molecular profiling. TUPRO-Melanoma is an exploratory project that aims to establish a comprehensive platform for in-depth tumour profiling in patients suffering from advanced melanoma. Aims of this platform are to establish logistics and algorithms for integrative analyses and discover new molecular biomarker profiles/patterns.

Primary Outcome Measures: Sample Processing and Report Generation, * 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), through study completion, an average of 1 year|Classification of proposed treatment options (according to the one of the 7 categories below), 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), through study completion, an average of 1 year|Classification of Tumour Board's recommendations according to ESCAT (categories below), 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, through study completion, an average of 1 year|Time to first subsequent treatment (TTFST), - Time to first subsequent treatment (TTFST), incl. best supportive care, through study completion, at least 6 month of follow up|Time to first subsequent treatment (TTFST) ratio, - Time to first subsequent treatment (TTFST) ratio (TTFST 2 / TTFST 1: TTFST 2 = TTFST on current project; TTFST 1 = TTFST on previous treatment \[before entering the project\]), through study completion, at least 6 month of follow up|Toxicity, - Frequency (proportion) of patients terminating treatment due to toxicity, through study completion, at least 6 month of follow up|Survival, - Overall survival (OS), calculated from registration until death due to any cause, through study completion, at least 6 month of follow up|Event free survival, - Event free survival (EFS), defined as time to treatment failure or death, through study completion, at least 6 month of follow up|Radiological tumour response, - Proportion of patients with a radiological tumour response (CR / PR) according to local standards and trial protocol (in case of referral or trial), through study completion, at least 6 month of follow up
Secondary Outcome Measures: Quality of life, - 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)., through study completion, at least 6 month of follow up