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

Melanoma Clinical Trial

— TUPRO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06463509
• Other study ID #: TUPRO-Melanoma
• Status: Completed
• Start date: January 8, 2019
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2024
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Other:
• Establishment of an in-deepth tumor profiling platform
In-depth tumor profiling beyond genomics

Locations

Country	Name	City	State
Switzerland	Department of Dermatology, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Reinhard Dummer

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Toxicity	- Frequency (proportion) of patients terminating treatment due to toxicity	through study completion, at least 6 month of follow up
Primary	Survival	- Overall survival (OS), calculated from registration until death due to any cause	through study completion, at least 6 month of follow up
Primary	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
Primary	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	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