Evaluating genomic profiling for advanced cancer treatment
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
This study is testing if using advanced genetic testing to guide treatment decisions can help people with advanced cancer live longer without their disease getting worse compared to older treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 235 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 5 sites (Innsbruck, Tirol and 4 other locations) |
| Trial ID | NCT05032092 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of comprehensive genomic tumor profiling (CGP) using liquid and/or tissue biopsies in patients with locally advanced or metastatic solid cancers. It will analyze how treatment decisions based on CGP impact progression-free survival (PFS) compared to previous therapies. A molecular tumor board will guide treatment decisions, utilizing a larger gene panel than previous studies, and the study will document the entire process, including treatment outcomes and costs. Insights gained may inform best practices for CGP-driven therapies in Austria and beyond.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed locally advanced or metastatic solid cancer who have experienced progression under their most recent therapy.
Not a fit: Patients with untreated central nervous system metastases or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with advanced cancers.
How similar studies have performed: Other studies have shown promise with genomic profiling approaches, but this study utilizes a notably larger gene panel, making it a potentially novel contribution.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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)
Where this trial is running
Innsbruck, Tirol and 4 other locations
- Medical University of Innsbruck, Department of Hematology and Oncology — Innsbruck, Tirol, Austria (Active_not_recruiting)
- Ordensklinikum Linz — Linz, Upper Austria, Austria (Recruiting)
- Landeskrankenhaus Feldkirch, Department of Internal Medicine II — Feldkirch, Vorarlberg, Austria (Recruiting)
- Medical University of Graz — Graz, Austria (Recruiting)
- University Hospital Salzburg, Department of Internal Medicine III — Salzburg, Austria (Recruiting)
Study contacts
- Principal investigator: Philipp Jost, Univ.Prof.Dr.MD, — Medical University of Graz, Department of Internal Medicine, Division of Clinical Oncology
- Study coordinator: Philipp Jost, Univ.Prof.Dr.MD
- Email: philipp.jost@medunigraz.at
- Phone: +43 316 385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.