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

Metastatic Cancer Clinical Trial

— SOUND  

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 Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05032092
• Other study ID #: 1168/2021
• Status: Recruiting
• Phase: N/A
• Start date: November 24, 2021
• Est. completion date: July 2024

Study information

• Verified date: April 2023
• Source: Medical University of Graz
• Contact: Armin Gerger, AssocProf.Priv.Doz.Dr.MD,MBA
• Phone: +43 316 385
• Email: armin.gerger[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Initial diagnosis of histologically confirmed locally advanced and/or metastatic carcinoma

• 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)

Related Conditions & MeSH terms

• Carcinoma
• Metastatic Cancer

Intervention

Diagnostic Test:
• Next Generation Sequencing
Molecular analysis of liquid biopsy.
• Next Generation Sequencing
Molecular analysis of tissue biopsy.

Genetic:
• Biomarker Monitoring
Biomarker Monitoring of study patients receiving matched therapy.

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Feldkirch, Department of Internal Medicine II	Feldkirch	Vorarlberg
Austria	Medical University of Graz	Graz
Austria	Medical University of Innsbruck, Department of Hematology and Oncology	Innsbruck	Tirol
Austria	Ordensklinikum Linz	Linz	Upper Austria
Austria	University Hospital Salzburg, Department of Internal Medicine III	Salzburg

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Start of treatment to radiomorphologically confirmed progression of disease, that is on average about 4 months
Secondary	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	Within seven days after NGS report at Molecular Tumour Board, i.e. 14 to 30 days after enrolment of patient
Secondary	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.	A maximum of 30 months after first patient first visit
Secondary	Calendar days from enrolment into the study to the date of death or last visit alive	To observe and describe overall survival (OS)	Enrolment to death or last visit alive, that is on average about 8 months
Secondary	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	A maximum of 30 months after first patient first visit
Secondary	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	A maximum of 30 months after first patient first visit