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Locally Advanced CarcinomaSOUNDNCT05032092

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

A study testing Next Generation Sequencing and Biomarker Monitoring in people with Locally Advanced Carcinoma and Metastatic Cancer, run by Medical University of Graz at 6 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Locally Advanced Carcinoma, Metastatic Cancer
What is being tested?
Next Generation Sequencing and Biomarker Monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
235 participants
Where
6 sitesAustria
Study dates
24 Nov 2021to 27 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Austria6 sites

  • Landesklinikum Amstetten

    Amstetten, 3300

  • Landeskrankenhaus Feldkirch, Department of Internal Medicine II

    Feldkirch, Vorarlberg, 6807

  • Medical University of Graz

    Graz, 8036

  • Medical University of Innsbruck, Department of Hematology and Oncology

    Innsbruck, Tyrol, 6020

  • Ordensklinikum Linz

    Linz, Upper Austria, 4010

  • University Hospital Salzburg, Department of Internal Medicine III

    Salzburg, State of Salzburg, 5020

Other trials in Austria

About this study

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.

Read the 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.

Being tested
Next Generation Sequencing, Biomarker Monitoring
Keywords
Comprehensive Genomic Tumour Profiling, Targeted Therapy, Progression Free Survival, Next Generation Sequencing, Molecular Tumour Board, Tumour-specific Therapy
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Next Generation SequencingDiagnostic test

    Also called FoundationOne®Liquid CDx

    Molecular analysis of liquid biopsy.

  • Next Generation SequencingDiagnostic test

    Also called FoundationOne® CDx

    Molecular analysis of tissue biopsy.

  • Biomarker MonitoringGenetic

    Also called AVENIO ctDNA Expanded Kit

    Biomarker Monitoring of study patients receiving matched therapy.

Study groups in NCT05032092
Study groupRoleWhat they receive
Adult patients with locally advanced and/or metastasized solid cancerExperimentalLiquid 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.
Receives: Diagnostic Test: Next Generation Sequencing; Genetic: Biomarker Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Start of treatment to radiomorphologically confirmed progression of disease, that is on average about 4 months

Secondary outcomes (5)

  1. 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

    Measured: Within seven days after NGS report at Molecular Tumour Board, i.e. 14 to 30 days after enrolment of patient

  2. 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.

    Measured: A maximum of 30 months after first patient first visit

  3. Calendar days from enrolment into the study to the date of death or last visit alive

    To observe and describe overall survival (OS)

    Measured: Enrolment to death or last visit alive, that is on average about 8 months

  4. 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

    Measured: A maximum of 30 months after first patient first visit

  5. 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

    Measured: A maximum of 30 months after first patient first visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2021
  2. Study start24 Nov 2021
  3. Primary completion14 Apr 2026
  4. Study completion27 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Open, Prospective, Multicentre IVD (in vitro diagnostic device) Study
Masking
None (open label)
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05032092
Sponsor's protocol ID
1168/2021
Acronym
SOUND
Status last verified
Aug 2026
First submitted
19 Aug 2021
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Next Generation Sequencing and Biomarker Monitoring in people with Locally Advanced Carcinoma and Metastatic Cancer, run by Medical University of Graz at 6 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05032092.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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