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

N/AActive Not RecruitingNCT05032092

Medical University of Graz235 enrolled

Overview

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.

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (6)

University Hospital Salzburg, Department of Internal Medicine III

Salzburg, State of 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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

Time frame: 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.

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: A maximum of 30 months after first patient first visit

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

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes