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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05032092

Studienbeginn:
November 2021

Letztes Update:
06.04.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Medical University of Graz

Collaborator:
-

Studienleiter

Armin Gerger, AssocProf.Priv.Doz.Dr.MD,MBA
Principal Investigator
Medical University of Graz, Department of Internal Medicine, Division of Clinical Oncology

Jakob Michael Riedl, Priv.Doz.Dr.scient.,MD.
Principal Investigator
Medical University of Graz, Department of Internal Medicine, Division of Clinical Oncology

Kontakt

Armin Gerger, AssocProf.Priv.Doz.Dr.MD,MBA
Kontakt:
Phone: +43 316 385
Phone (ext.): 80625
E-Mail: armin.gerger@medunigraz.at» Kontaktdaten anzeigen

Sarah Steinlechner, BSc, MSc, MSc
Kontakt:
Phone: +43 316 385
Phone (ext.): 78064
E-Mail: sarah.steinlechner@medunigraz.at» Kontaktdaten anzeigen

Studienlocations
(3 von 5)

Medical University of Innsbruck, Department of Hematology and Oncology
6020 Innsbruck
AustriaAktiv, nicht rekrutierend» Google-Maps

Ordensklinikum Linz
4010 Linz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Holger Rumpold, AssPr PD MD
E-Mail: holger.rumpold@ordensklinikum.at» Ansprechpartner anzeigen

Landeskrankenhaus Feldkirch, Department of Internal Medicine II
6807 Feldkirch
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Thomas Winder, PD M.D. PhD
E-Mail: thomas.winder@lkhf.at» Ansprechpartner anzeigen

Medical University of Graz
8036 Graz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Armin Gerger, AssocProf.MD
Phone: +43 316 385 80625
E-Mail: armin.gerger@medunigraz.at» Ansprechpartner anzeigen

University Hospital Salzburg, Department of Internal Medicine III
5020 Salzburg
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Richard Greil, Prof. M.D.
E-Mail: r.greil@salk.at» Ansprechpartner anzeigen

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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)

Studien-Rationale

Primary outcome:

1. Proportion of patients with Progression Free Survival (PFS): (matched therapy) /PFS (most recent therapy) > 1.3 (Time Frame - Start of treatment to radiomorphologically confirmed progression of disease, that is on average about 4 months):
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:

1. Number of potentially actionable targets (Time Frame - Within seven days after NGS report at Molecular Tumour Board, i.e. 14 to 30 days after enrolment of patient):
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

2. Proportion of patients with potentially actionable targets (Time Frame - A maximum of 30 months after first patient first visit):
To investigate the proportion of patients with targets actionable by an approved drug on-label, off-label or an experimental drug.

3. Calendar days from enrolment into the study to the date of death or last visit alive (Time Frame - Enrolment to death or last visit alive, that is on average about 8 months):
To observe and describe overall survival (OS)

4. Proportion of patients with best overall response of either complete response (CR) or partial response (PR), based on their overall response (Time Frame - A maximum of 30 months after first patient first visit):
To observe and describe objective response rate (ORR), Response will be evaluated by the investigator as defined by RECIST 1. or irRECIST

5. Proportion of patients with successful molecular profiling from liquid or tissue biopsy, in whom a matched therapy was recommended (Time Frame - A maximum of 30 months after first patient first visit):
To investigate the proportion of patients with successful molecular profiling

Geprüfte Regime

Next Generation Sequencing (FoundationOne®Liquid CDx):
Molecular analysis of liquid biopsy.
Next Generation Sequencing (FoundationOne® CDx):
Molecular analysis of tissue biopsy.
Biomarker Monitoring (AVENIO ctDNA Surveillance Kit):
Biomarker Monitoring of study patients receiving matched therapy.

Quelle: ClinicalTrials.gov

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