Clinical trial NCT05032092: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Locally Advanced Carcinoma
Metastatic Cancer
Keywords: Comprehensive Genomic Tumour Profiling
Targeted Therapy
Progression Free Survival
Next Generation Sequencing
Molecular Tumour Board
Tumour-specific Therapy
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open, Prospective, Multicentre IVD (in vitro diagnostic device) Study
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Proportion of patients with Progression Free Survival (PFS): (matched therapy) /PFS (most recent therapy) > 1.3
timeFrame: Start of treatment to radiomorphologically confirmed progression of disease, that is on average about 4 months
Secondary outcomes:
measure: Number of potentially actionable targets
timeFrame: Within seven days after NGS report at Molecular Tumour Board, i.e. 14 to 30 days after enrolment of patient
measure: Proportion of patients with potentially actionable targets
timeFrame: A maximum of 30 months after first patient first visit
measure: Calendar days from enrolment into the study to the date of death or last visit alive
timeFrame: Enrolment to death or last visit alive, that is on average about 8 months
measure: Proportion of patients with best overall response of either complete response (CR) or partial response (PR), based on their overall response
timeFrame: A maximum of 30 months after first patient first visit
measure: Proportion of patients with successful molecular profiling from liquid or tissue biopsy, in whom a matched therapy was recommended
timeFrame: A maximum of 30 months after first patient first visit
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck, Department of Hematology and Oncology
state: Tirol
city: Linz
country: Austria
facility: Ordensklinikum Linz
state: Upper Austria
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch, Department of Internal Medicine II
state: Vorarlberg
city: Graz
country: Austria
facility: Medical University of Graz
city: Salzburg
country: Austria
facility: University Hospital Salzburg, Department of Internal Medicine III
Study officials:
affiliation: Medical University of Graz, Department of Internal Medicine, Division of Clinical Oncology
name: Philipp Jost, Univ.Prof.Dr.MD,
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Graz, Department of Internal Medicine, Division of Clinical Oncology
name: Armin Gerger, Univ.Prof.,MD.
role: PRINCIPAL_INVESTIGATOR
References: