SOUND: Evaluation of Efficacy of Comprehensive Genomic Tumour Profiling (CGP) From Liquid and/or Tissue Biopsy in Patients With Locally Advanced and/or Metastatic Carcinoma
Study Details
Study Description
Brief Summary
The aims of this study are
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to evaluate the efficacy of comprehensive genomic tumour profiling (CGP) from liquid and/or tissue biopsy in patients with locally advanced and/or metastatic carcinoma.
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to evaluate and describe the impact of treatment decisions based on CGP on individual progression free survival in patients with locally advanced and/or metastatic carcinoma
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to evaluate and describe similarities and differences between the treatment suggestions based on CGP/IHC (immuno-histochemistry) of tissue biopsy and liquid biopsy.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Adult patients with locally advanced and/or metastasized carcinoma Liquid biopsies of all 200 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 Surveillance Kit. |
Diagnostic Test: Next Generation Sequencing
Molecular analysis of liquid biopsy.
Other Names:
Diagnostic Test: Next Generation Sequencing
Molecular analysis of tissue biopsy.
Other Names:
Genetic: Biomarker Monitoring
Biomarker Monitoring of study patients receiving matched therapy.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients with Progression Free Survival (PFS): (matched therapy) /PFS (most recent therapy) > 1.3 [Start of treatment to radiomorphologically confirmed progression of disease, that is on average about 4 months]
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
Secondary Outcome Measures
- Number of potentially actionable targets [Within seven days after NGS report at Molecular Tumour Board, i.e. 14 to 30 days after enrolment of patient]
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
- Proportion of patients with potentially actionable targets [A maximum of 30 months after first patient first visit]
To investigate the proportion of patients with targets actionable by an approved drug on-label, off-label or an experimental drug.
- Calendar days from enrolment into the study to the date of death or last visit alive [Enrolment to death or last visit alive, that is on average about 8 months]
To observe and describe overall survival (OS)
- Proportion of patients with best overall response of either complete response (CR) or partial response (PR), based on their overall response [A maximum of 30 months after first patient first visit]
To observe and describe objective response rate (ORR), Response will be evaluated by the investigator as defined by RECIST 1. or irRECIST
- Proportion of patients with successful molecular profiling from liquid or tissue biopsy, in whom a matched therapy was recommended [A maximum of 30 months after first patient first visit]
To investigate the proportion of patients with successful molecular profiling
Eligibility Criteria
Criteria
Inclusion Criteria:
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Initial diagnosis of histologically confirmed locally advanced and/or metastatic carcinoma
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Radiologically confirmed progression under the most recent therapy
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No further evidence-based drug treatment is established, or no satisfactory alternative treatments are available for the locally advanced and/or metastasized carcinoma
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Further therapy is medically feasible
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ECOG (Eastern Cooperative Oncology Group) performance status 0-2
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Life expectancy of at least 12 weeks
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Written informed consent and willingness to cooperate during the course of the study
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Capability to understand the intention and the consequences of the study
Exclusion Criteria:
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Untreated CNS (central nervous system) metastases. Patients with treated CNS metastases are eligible if they are clinically stable with regard to neurologic function
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Pregnant or breast feeding
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Other malignomas, diagnosed < 5a before inclusion (except localized squamous cell carcinomas of the skin, surgically curable melanomas of the skin, basal cell carcinomas of the skin)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of Innsbruck, Department of Hematology and Oncology | Innsbruck | Tirol | Austria | 6020 |
| 2 | Ordensklinikum Linz | Linz | Upper Austria | Austria | 4010 |
| 3 | Landeskrankenhaus Feldkirch, Department of Internal Medicine II | Feldkirch | Vorarlberg | Austria | 6807 |
| 4 | Medical University of Graz | Graz | Austria | 8036 | |
| 5 | University Hospital Salzburg, Department of Internal Medicine III | Salzburg | Austria | 5020 |
Sponsors and Collaborators
- Medical University of Graz
Investigators
- Principal Investigator: Armin Gerger, AssocProf.MD, Medical University of Graz, Department of Internal Medicine, Division of Clinical Oncology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1168/2021