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 (SOUND)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Cancer; Locally Advanced Carcinoma
• Intervention / Treatment: Diagnostic test: Next Generation Sequencing; Diagnostic test: Next Generation Sequencing; Genetic: Biomarker Monitoring

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 Type: Interventional
• Enrollment (Estimated): 235
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Amstetten, Austria, 3300
    • Landesklinikum Amstetten
  • Graz, Austria, 8036
    • Medical University of Graz
  • Salzburg
    • Salzburg, Salzburg, Austria, 5020
      • University Hospital Salzburg, Department of Internal Medicine III
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Medical University of Innsbruck, Department of Hematology and Oncology
  • Upper Austria
    • Linz, Upper Austria, Austria, 4010
      • Ordensklinikum Linz
  • Vorarlberg
    • Feldkirch, Vorarlberg, Austria, 6807
      • Landeskrankenhaus Feldkirch, Department of Internal Medicine II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Initial diagnosis of histologically confirmed locally advanced and/or metastatic solid cancer
• Radiologically confirmed progression under the most recent therapy
• No further evidence-based drug treatment is established, or no satisfactory alternative treatments are available for the locally advanced and/or metastasized carcinoma
• 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 Criteria:

• Untreated CNS (central nervous system) metastases. Patients with treated CNS metastases are eligible if they are clinically stable with regard to neurologic function
• Pregnant or breast feeding
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Adult patients with locally advanced and/or metastasized solid cancer; 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.

Diagnostic test: Next Generation Sequencing; Molecular analysis of liquid biopsy.; Other Names: FoundationOne®Liquid CDx; Diagnostic test: Next Generation Sequencing; Molecular analysis of tissue biopsy.; Other Names: FoundationOne® CDx; Genetic: Biomarker Monitoring; Biomarker Monitoring of study patients receiving matched therapy.; Other Names: AVENIO ctDNA Expanded Kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Progression Free Survival; Next Generation Sequencing; Targeted Therapy; Comprehensive Genomic Tumour Profiling; Molecular Tumour Board; Tumour-specific Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis
• Other Study ID Numbers: 1168/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No