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

Primary Purpose

Locally Advanced Carcinoma, Metastatic Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Next Generation Sequencing

Biomarker Monitoring

About this trial

This is an interventional diagnostic trial for Locally Advanced Carcinoma focused on measuring Comprehensive Genomic Tumour Profiling, Targeted Therapy, Progression Free Survival, Next Generation Sequencing, Molecular Tumour Board, Tumour-specific Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Medical University of Innsbruck, Department of Hematology and Oncology
Ordensklinikum LinzRecruiting
Landeskrankenhaus Feldkirch, Department of Internal Medicine IIRecruiting
Medical University of GrazRecruiting
University Hospital Salzburg, Department of Internal Medicine IIIRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adult patients with locally advanced and/or metastasized carcinoma

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

Calendar days from enrolment into the study to the date of death or last visit alive

To observe and describe overall survival (OS)

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

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

Full Information

NCT ID

NCT05032092

First Posted

August 19, 2021

Last Updated

April 5, 2023

Sponsor

Medical University of Graz

1. Study Identification

Unique Protocol Identification Number

NCT05032092

Brief 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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 24, 2021 (Actual)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Carcinoma, Metastatic Cancer

Keywords

Comprehensive Genomic Tumour Profiling, Targeted Therapy, Progression Free Survival, Next Generation Sequencing, Molecular Tumour Board, Tumour-specific Therapy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Adult patients with locally advanced and/or metastasized carcinoma

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Next Generation Sequencing

Other Intervention Name(s)

FoundationOne®Liquid CDx

Intervention Description

Molecular analysis of liquid biopsy.

Intervention Type

Diagnostic Test

Intervention Name(s)

Next Generation Sequencing

Other Intervention Name(s)

FoundationOne® CDx

Intervention Description

Molecular analysis of tissue biopsy.

Intervention Type

Genetic

Intervention Name(s)

Biomarker Monitoring

Other Intervention Name(s)

AVENIO ctDNA Surveillance Kit

Intervention Description

Biomarker Monitoring of study patients receiving matched therapy.

Primary Outcome Measure Information:

Title

Proportion of patients with Progression Free Survival (PFS): (matched therapy) /PFS (most recent therapy) > 1.3

Description

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 Outcome Measure Information:

Title

Number of potentially actionable targets

Description

Time Frame

Within seven days after NGS report at Molecular Tumour Board, i.e. 14 to 30 days after enrolment of patient

Title

Proportion of patients with potentially actionable targets

Description

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

Title

Calendar days from enrolment into the study to the date of death or last visit alive

Description

To observe and describe overall survival (OS)

Time Frame

Enrolment to death or last visit alive, that is on average about 8 months

Title

Proportion of patients with best overall response of either complete response (CR) or partial response (PR), based on their overall response

Description

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

Title

Proportion of patients with successful molecular profiling from liquid or tissue biopsy, in whom a matched therapy was recommended

Description

To investigate the proportion of patients with successful molecular profiling

Time Frame

A maximum of 30 months after first patient first visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

+43 316 385

Ext

80625

armin.gerger@medunigraz.at

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah Steinlechner, BSc, MSc, MSc

Phone

+43 316 385

Ext

78064

sarah.steinlechner@medunigraz.at

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Innsbruck, Department of Hematology and Oncology

City

Innsbruck

State/Province

Tirol

ZIP/Postal Code

6020

Country

Austria

Individual Site Status

Active, not recruiting

Facility Name

Ordensklinikum Linz

City

Linz

State/Province

Upper Austria

ZIP/Postal Code

4010

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Holger Rumpold, AssPr PD MD

holger.rumpold@ordensklinikum.at

Facility Name

Landeskrankenhaus Feldkirch, Department of Internal Medicine II

City

Feldkirch

State/Province

Vorarlberg

ZIP/Postal Code

6807

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Winder, PD M.D. PhD

thomas.winder@lkhf.at

Facility Name

Medical University of Graz

City

Graz

ZIP/Postal Code

8036

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Armin Gerger, AssocProf.MD

Phone

+43 316 385 80625

armin.gerger@medunigraz.at

Facility Name

University Hospital Salzburg, Department of Internal Medicine III

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Richard Greil, Prof. M.D.

r.greil@salk.at

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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