Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Neoplasm Metastasis

Disease Progression

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Liquid biopsies of all 200 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 Surveillance Kit.

Next Generation Sequencing

Biomarker Monitoring of study patients receiving matched therapy.

Biomarker Monitoring

Armin Gerger, AssocProf.Priv.Doz.Dr.MD,MBA

Sarah Steinlechner, BSc, MSc, MSc

Holger Rumpold, AssPr PD MD

Thomas Winder, PD M.D. PhD

Armin Gerger, AssocProf.MD

Richard Greil, Prof. M.D.

Jakob Michael Riedl, Priv.Doz.Dr.scient.,MD.

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 carcinoma.
* 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 carcinoma
* 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.

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.

Open, Prospective, Multicentre IVD (in vitro diagnostic device) Study

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

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

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

To investigate the proportion of patients with targets actionable by an approved drug on-label, off-label or an experimental drug.

To observe and describe overall survival (OS)

To observe and describe objective response rate (ORR), Response will be evaluated by the investigator as defined by RECIST 1. or irRECIST

To investigate the proportion of patients with successful molecular profiling

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of Efficacy of Comprehensive Genomic Tumour Profiling (CGP) From Liquid and/or Tissue Biopsy in Patients With Locally Advanced and/or Metastatic Carcinoma	NCT05032092	Locally Advance... Metastatic Canc...	Next Generation... Next Generation... Biomarker Monit...	18 Years -	Medical University of Graz
Evaluation of Efficacy of Comprehensive Genomic Tumour Profiling (CGP) From Liquid and/or Tissue Biopsy in Patients With Locally Advanced and/or Metastatic Carcinoma	NCT05032092	Locally Advance... Metastatic Canc...	Next Generation... Next Generation... Biomarker Monit...	18 Years -	Medical University of Graz

Spots Global Cancer Trial Database for biomarker monitoring