Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Carcinoma | Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biomarker Monitoring | Genetic | — | UNRESOLVED |
| Next Generation Sequencing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adult patients with locally advanced and/or metastasized solid cancer
- description
- 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.
- interventionNames
- Diagnostic Test: Next Generation Sequencing
- Genetic: Biomarker Monitoring
Primary outcomes (1)
- measure
- Proportion of patients with Progression Free Survival (PFS): (matched therapy) /PFS (most recent therapy) > 1.3
- timeFrame
- Start of treatment to radiomorphologically confirmed progression of disease, that is on average about 4 months
- 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
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
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