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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05032092
Other study ID # 1168/2021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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