Cancer tumors
Conditions
Interventions
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • (suspicion of) stage IV disease from solid tumors; • collection of tumor material (biopsy, resection, or body fluid containing tumor cells) can safely be obtained during routine diagnostic procedures; • a routine diagnostic procedure in case of newly collected tumor material or routine molecular diagnostic procedure in case of fresh frozen archival tumor material or tumor material collected in the context of a research/translational study; • treatment will be received at the Antoni van Leeuwenhoek; • age 18 years or older, willing and able to comply with the protocol as judged by the investigator; • written informed consent.
Exclusion criteria
Exclusion criteria: • Age below 18 years; • No metastatic disease or suspicion of metastatic disease; • Archival tumor material of a patient who has received immune and/or targeted therapy after collection of tumor tissue; • Prior participation in WIDE with a successful WGS analysis unless it concerns molecular analysis for resistance to tyrosine kinase inhibitors; • Allogeneic stem cell transplantation or transplantation of the organ in which the tumor originated or is located
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Feasibility: The percentage of samples that successfully been processed from biopsy to WGS report in an acceptable turnaround time (2-3 weeks). • Clinical validation: The percentage of samples for which WGS minimally reports the same treatment-relevant variants as SOC DNA diagnostics (e.g. next generation sequencing (NGS) panels, RNA-based NGS fusion analysis, Sanger sequencing, RT PCRs, and FISH) • Health Technology Assessment of WGS as compared to SOC diagnostics. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Additional treatment options: the percentage of patients for whom potential treatment options (in clinical trials) are identified by WGS that have not been identified using SOC diagnostic assays performed for this patient. • Better informed decision making/experience of the treating physician: the opinion of treating physicians on the added value of WGS for decision making compared to SOC diagnostics. This will be evaluated with questionnaires for the treating physician and is a qualitative analysis. • Expanding the HMF database: the number of patients whose clinical and WGS data is added to the HMF database | — |
Countries
The Netherlands
Outcome results
None listed