Clinical trial NCT06463509: Establishment and Standardization of a Platform for In-depth Tumour Profiling (TUPRO) in Patients With Melanoma
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 116
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced melanoma (stage III or IV cutaneous melanoma, or rare melanoma subtypes at any stage that require systemic therapy)

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* ECOG performance status ≤2 (not bedridden for more than 50% of waking hours)
* Stage III or IV cutaneous melanoma, or rare melanoma subtypes at any stage that require systemic therapy
* Written informed consent according to national legal and regulatory requirements prior to any project specific procedures

Exclusion Criteria:

* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the sponsor-project leader or site project leader may interfere with the project or affect patient compliance
* Legal incompetence

Primary outcomes:
measure: Sample Processing and Report Generation
timeFrame: through study completion, an average of 1 year
measure: Classification of proposed treatment options (according to the one of the 7 categories below)
timeFrame: through study completion, an average of 1 year
measure: Classification of Tumour Board's recommendations according to ESCAT (categories below)
timeFrame: through study completion, an average of 1 year
measure: Time to first subsequent treatment (TTFST)
timeFrame: through study completion, at least 6 month of follow up
measure: Time to first subsequent treatment (TTFST) ratio
timeFrame: through study completion, at least 6 month of follow up
measure: Toxicity
timeFrame: through study completion, at least 6 month of follow up
measure: Survival
timeFrame: through study completion, at least 6 month of follow up
measure: Event free survival
timeFrame: through study completion, at least 6 month of follow up
measure: Radiological tumour response
timeFrame: through study completion, at least 6 month of follow up
Secondary outcomes:
measure: Quality of life
timeFrame: through study completion, at least 6 month of follow up
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Dermatology, University Hospital Zurich
Study officials:
References: