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

NCT ID: NCT05032092

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 235 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-24
• Study Completion Date: 2027-12-31

Brief 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.

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.

Conditions

Locally Advanced Carcinoma; Metastatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Next Generation Sequencing

Intervention Type: DIAGNOSTIC_TEST

Molecular analysis of liquid biopsy.

Next Generation Sequencing

Intervention Type: DIAGNOSTIC_TEST

Molecular analysis of tissue biopsy.

Biomarker Monitoring

Intervention Type: GENETIC

Biomarker Monitoring of study patients receiving matched therapy.

Interventions

Next Generation Sequencing

Molecular analysis of liquid biopsy.

Intervention Type: DIAGNOSTIC_TEST

Next Generation Sequencing

Molecular analysis of tissue biopsy.

Intervention Type: DIAGNOSTIC_TEST

Biomarker Monitoring

Biomarker Monitoring of study patients receiving matched therapy.

Intervention Type: GENETIC

Other Intervention Names

FoundationOne®Liquid CDx; FoundationOne® CDx; AVENIO ctDNA Expanded Kit

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philipp Jost, Univ.Prof.Dr.MD,

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Department of Internal Medicine, Division of Clinical Oncology

Armin Gerger, Univ.Prof.,MD.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Department of Internal Medicine, Division of Clinical Oncology

Locations

University Hospital Salzburg, Department of Internal Medicine III

Salzburg, Salzburg, Austria

Medical University of Innsbruck, Department of Hematology and Oncology

Innsbruck, Tyrol, Austria

Ordensklinikum Linz

Linz, Upper Austria, Austria

Landeskrankenhaus Feldkirch, Department of Internal Medicine II

Feldkirch, Vorarlberg, Austria

Landesklinikum Amstetten

Amstetten, , Austria

Medical University of Graz

Graz, , Austria

Countries

Austria

Other Identifiers

1168/2021

Identifier Type: -

Identifier Source: org_study_id