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The aims of this study are
In patients with locally advanced and/or metastatic carcinoma the primary efficacy objective of the study is, to observe and describe the PFS (progression-free survival) of the matched treatment compared to the PFS of the most recent therapy.
The SOUND study will be exploring the treatment rates and outcomes of CGP-driven targeted treatment in patients with advanced or metastasized cancer. It will use a substantially larger gene-panel than previous studies in Austria. Departing from the routine clinical practice, study patients will have the opportunity to have CGP from liquid and/or tissue biopsy. The treatment decision will be discussed within a molecular tumour board consisting of experts in clinical oncology, human genetics and pathology. The treatment decision process will be supported and documented by a software.
Data from the SOUND study will cover the whole analysis process, the reasons for the treatment decision, reasons for getting or not-getting a matched treatment as well as the outcome, treatment and hospitalisation costs. The SOUND study will give valuable insights into the clinical practice of CGP-driven therapy in Austria and describe the experience and the possible restrictions. Considering the differing conditions in Austria, the SOUND study will generate data that might be useful for best practice sharing with other countries in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients with locally advanced and/or metastasized solid cancer | Experimental | Liquid biopsies of all 235 study patients will be analysed with FoundationOne®Liquid CDx. Tissue biopsies from all study patients for whom a tissue biopsy is available will be analysed with FoundationOne® CDx and IHC (approximately 50% of the enrolled patients). Biomarker Monitoring of study patients receiving matched therapy with AVENIO ctDNA Expanded Kit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Next Generation Sequencing | Diagnostic Test | Molecular analysis of liquid biopsy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with Progression Free Survival (PFS): (matched therapy) /PFS (most recent therapy) > 1.3 | To observe and describe the PFS of the matched treatment compared to the PFS of the most recent therapy, PFS = number of calendar days from start treatment to progression of disease | Start of treatment to radiomorphologically confirmed progression of disease, that is on average about 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of potentially actionable targets | To evaluate the number of targets identified with NGS (next-generation sequencing) and IHC, that are potentially actionable with an approved drug on-label, off-label or an experimental drug per patient | Within seven days after NGS report at Molecular Tumour Board, i.e. 14 to 30 days after enrolment of patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philipp Jost, Univ.Prof.Dr.MD, | Medical University of Graz, Department of Internal Medicine, Division of Clinical Oncology | Principal Investigator |
| Armin Gerger, Univ.Prof.,MD. | Medical University of Graz, Department of Internal Medicine, Division of Clinical Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Salzburg, Department of Internal Medicine III | Salzburg | State of Salzburg | 5020 | Austria | ||
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Open, Prospective, Multicentre IVD (in vitro diagnostic device) Study
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| Next Generation Sequencing | Diagnostic Test | Molecular analysis of tissue biopsy. |
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| Biomarker Monitoring | Genetic | Biomarker Monitoring of study patients receiving matched therapy. |
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| Proportion of patients with potentially actionable targets | To investigate the proportion of patients with targets actionable by an approved drug on-label, off-label or an experimental drug. | A maximum of 30 months after first patient first visit |
| Calendar days from enrolment into the study to the date of death or last visit alive | To observe and describe overall survival (OS) | Enrolment to death or last visit alive, that is on average about 8 months |
| Proportion of patients with best overall response of either complete response (CR) or partial response (PR), based on their overall response | To observe and describe objective response rate (ORR), Response will be evaluated by the investigator as defined by RECIST 1. or irRECIST | A maximum of 30 months after first patient first visit |
| Proportion of patients with successful molecular profiling from liquid or tissue biopsy, in whom a matched therapy was recommended | To investigate the proportion of patients with successful molecular profiling | A maximum of 30 months after first patient first visit |
| Medical University of Innsbruck, Department of Hematology and Oncology |
| Innsbruck |
| Tyrol |
| 6020 |
| Austria |
| Ordensklinikum Linz | Linz | Upper Austria | 4010 | Austria |
| Landeskrankenhaus Feldkirch, Department of Internal Medicine II | Feldkirch | Vorarlberg | 6807 | Austria |
| Landesklinikum Amstetten | Amstetten | 3300 | Austria |
| Medical University of Graz | Graz | 8036 | Austria |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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