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

NCT05032092 | Active Not Recruiting DMC

• 1 other identifier: 1168/2021
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 6

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of potentially actionable targets

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

• Proportion of patients with potentially actionable targets

  A maximum of 30 months after first patient first visit

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

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

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

  A maximum of 30 months after first patient first visit

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

  A maximum of 30 months after first patient first visit

Study Arms (1)

Adult patients with locally advanced and/or metastasized solid cancer

EXPERIMENTAL

Liquid biopsies of all 235 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 Expanded Kit.

Diagnostic Test: Next Generation Sequencing; Genetic: Biomarker Monitoring

Interventions

Next Generation Sequencing DIAGNOSTIC_TEST

Molecular analysis of liquid biopsy.

Also known as: FoundationOne®Liquid CDx

Adult patients with locally advanced and/or metastasized solid cancer

Biomarker Monitoring GENETIC

Biomarker Monitoring of study patients receiving matched therapy.

Also known as: AVENIO ctDNA Expanded Kit

Adult patients with locally advanced and/or metastasized solid cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (6)

University Hospital Salzburg, Department of Internal Medicine III

Salzburg, Salzburg, 5020, Austria

Location

Medical University of Innsbruck, Department of Hematology and Oncology

Innsbruck, Tyrol, 6020, Austria

Location

Ordensklinikum Linz

Linz, Upper Austria, 4010, Austria

Location

Landeskrankenhaus Feldkirch, Department of Internal Medicine II

Feldkirch, Vorarlberg, 6807, Austria

Location

Landesklinikum Amstetten

Amstetten, 3300, Austria

Location

Medical University of Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philipp Jost, Univ.Prof.Dr.MD,

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

  PRINCIPAL INVESTIGATOR

• Armin Gerger, Univ.Prof.,MD.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: September 2, 2021
• Study Start: November 24, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6)