Metastatic Solid Tumor
Conditions
Brief summary
The traditional approach to cancer treatment has changes from using drugs approved for the specific cancer diagnosis to a tumor agnostic approach when treating solid tumors. How often will tumor biopsy and genomic profiling in patients with advanced solid tumors with no further evidence based treatment options result in biomarker-driven targeted treatment ? Feasibility of the investigation of patients and median turnaround time from biopsy to available genomic profile is evaluated.
Detailed description
Genomic profiling in patients with advanced solid tumors and no further evidence based treatment options is a newer approach. The frequency of genomic alterations varies between individual tumor types and the actionability of somatic variants are different but evolves in line with the development of new targeted drugs. In accordance with expected short survival short assessment time is important to minimize the risk of patient detoriation during the investigation. A fresh biopsy from lesions in progression is preferred for analysis. To minimize the duration of the genomic profiling a genpanel analysis covering the most frequent oncogene targets is preferred. The primary objective is to evaluate the feasibility of the investigational procedures. The secondary objective is to investigate how often genomic changes in tumor tissue gives rise to a targeted treatment offer and to evaluate the clinical benefit using the Growth Modulation Index.
Interventions
next generation sequencing
Sponsors
Study design
Intervention model description
prospective, single-center cohorte study
Eligibility
Inclusion criteria
* Written informed consent * Age ≥ 18 years * Diagnosis of advanced solid tumors * Evidence based treatment options are exhausted * Performance Status 0-2 * Adequate organ function * Life expectancy of at least 3 months
Exclusion criteria
• inclusions criteria not met
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Turn around time genomic profiling | through study completion, an average of 2 year | Time from date of biopsi to date of available genomic profile discussed at tumor board meeting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequenc of matched treatment offer | through study completion, an average of 2 year | Number of patients offered a treatment based on the genomic profile |
Countries
Denmark