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)

November 18, 2025 updated by: Medical University of Graz

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
235

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with Progression Free Survival (PFS): (matched therapy) /PFS (most recent therapy) > 1.3
Time Frame: 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
Start of treatment to radiomorphologically confirmed progression of disease, that is on average about 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of potentially actionable targets
Time Frame: 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
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
Time Frame: 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.
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
Time Frame: Enrolment to death or last visit alive, that is on average about 8 months
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
Time Frame: 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
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
Time Frame: A maximum of 30 months after first patient first visit
To investigate the proportion of patients with successful molecular profiling
A maximum of 30 months after first patient first visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Graz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 24, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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