Evaluation of Efficacy of Comprehensive Genomic Tumour Profiling (CGP) From Liquid and/or Tissue Biopsy in Patients With Locally Advanced and/or Metastatic Solid Cancer

Last updated: November 18, 2025
Sponsor: Medical University of Graz
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Metastatic Cancer

Neoplasm Metastasis

Carcinoma

Treatment

Next Generation Sequencing

Biomarker Monitoring

Clinical Study ID

NCT05032092
1168/2021
  • Ages > 18
  • All Genders

Study Summary

The aims of this study are

  • to evaluate the efficacy of comprehensive genomic tumour profiling (CGP) from liquid and/or tissue biopsy in patients with locally advanced and/or metastatic solid cancer.

  • 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 solid cancer

  • 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Initial diagnosis of histologically confirmed locally advanced and/or metastaticsolid cancer

  • Radiologically confirmed progression under the most recent therapy

  • No further evidence-based drug treatment is established, or no satisfactoryalternative treatments are available for the locally advanced and/or metastasizedcarcinoma

  • Further therapy is medically feasible

  • ECOG (Eastern Cooperative Oncology Group) performance status 0-2

  • Life expectancy of at least 12 weeks

  • Written informed consent and willingness to cooperate during the course of the study

  • Capability to understand the intention and the consequences of the study

Exclusion

Exclusion Criteria:

  • Untreated CNS (central nervous system) metastases. Patients with treated CNSmetastases are eligible if they are clinically stable with regard to neurologicfunction

  • Pregnant or breast feeding

  • Other malignomas, diagnosed < 5a before inclusion (except localized squamous cellcarcinomas of the skin, surgically curable melanomas of the skin, basal cellcarcinomas of the skin)

Study Design

Total Participants: 235
Treatment Group(s): 2
Primary Treatment: Next Generation Sequencing
Phase:
Study Start date:
November 24, 2021
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • University Hospital Salzburg, Department of Internal Medicine III

    Salzburg 2766824, Salzburg 2766823 5020
    Austria

    Site Not Available

  • Medical University of Innsbruck, Department of Hematology and Oncology

    Innsbruck, Tirol 6020
    Austria

    Site Not Available

  • Medical University of Innsbruck, Department of Hematology and Oncology

    Innsbruck 2775220, Tyrol 2763586 6020
    Austria

    Site Not Available

  • Ordensklinikum Linz

    Linz, Upper Austria 4010
    Austria

    Site Not Available

  • Ordensklinikum Linz

    Linz 2772400, Upper Austria 2769848 4010
    Austria

    Site Not Available

  • Landeskrankenhaus Feldkirch, Department of Internal Medicine II

    Feldkirch, Vorarlberg 6807
    Austria

    Site Not Available

  • Landeskrankenhaus Feldkirch, Department of Internal Medicine II

    Feldkirch 2779674, Vorarlberg 2762300 6807
    Austria

    Site Not Available

  • Landesklinikum Amstetten

    Amstetten 2782555, 3300
    Austria

    Site Not Available

  • Medical University of Graz

    Graz, 8036
    Austria

    Site Not Available

  • Medical University of Graz

    Graz 2778067, 8036
    Austria

    Site Not Available

  • University Hospital Salzburg, Department of Internal Medicine III

    Salzburg, 5020
    Austria

    Site Not Available

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